CHL
ABL90 FLEX
- Advisory panel
- Clinical Chemistry
- Total cleared
- 188
Adverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code CHL
1–100 of 188- K252207 — ABL90 FLEX PLUS System, safeCLINITUBES
- K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System
- K240998 — ABL90 FLEX PLUS System
- K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K221900 — Stat Profile Prime Plus Analyzer System
- K223857 — i-STAT G3+ cartridge with the i-STAT 1 System
- K223608 — GEM Premier 7000 with IQM3
- K211559 — EasyStat 300
- K203790 — GEM Premier 5000
- K200986 — OPTI® B-Lac Cassette
- K200107 — epoc Blood Analysis System
- K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System
- K192240 — RAPIDPoint 500e Blood Gas System
- K193246 — Stat Profile Prime Plus Analyzer System
- K173797 — Stat Profile Prime Plus Analyzer System
- K173403 — GEM Premier 5000
- K160412 — GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
- K160153 — ABL90 FLEX PLUS
- K151978 — EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
- K151982 — Stat Profile Prime ABG Analyzer System
- K151856 — ABL80 FLEX CO-OX with AQURE connectivity
- K142898 — ABL800 FLEX with AQURE connectivity
- K141907 — STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
- K142220 — Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
- K131703 — NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
- K133407 — GEM PREMIER 4000
- K131988 — ABL90 FLEX ANALYZER
- K131126 — OPTI CCA-TS2
- K130144 — ABL90 FLEX
- K123748 — ABL90 FLEX
- K122539 — MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
- K122729 — ABL90 FLEX
- K122642 — ABL90 FLEX
- K111188 — COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
- K120197 — ABL90 FLEX
- K110648 — NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
- K111897 — ABL90
- K110416 — ABL835 FLEX ANALYZER WITH PLEURAL PH
- K093280 — OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
- K100777 — ABL837 FLEX ANALYZER
- K080370 — ABL 80 CO-OX SYSTEM
- K063376 — EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
- K061974 — GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
- K051804 — ABL80 FLEX ANALYZER
- K043218 — ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
- K050423 — OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
- K041874 — ABL800 FLEX
- K031560 — BAYER RAPIDLAB 1200 SYSTEM
- K023567 — STAT PROFILE PHOX PLUS L ANALYZER
- K022746 — STAT PROFILE CRITICAL CARE XPRESS ANALYZER
- K021713 — STAT PROFILE PHOX PLUS C ANALYZER
- K021515 — EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
- K020297 — STAT PROFILE CRITICAL CARE XPRESS ANALYZER
- K014295 — STAT PROFILE PHOX ANALYZER
- K013729 — STAT PROFILE PHOX BASIC ANALYZER
- K012058 — STAT PROFILE PHOX PLUS L ANALYZER
- K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
- K002738 — BAYER RAPIDPOINT 400 SYSTEM
- K002613 — MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
- K002290 — ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
- K000103 — AVL OPTI R ANALYZER
- K994346 — ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
- K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
- K993789 — CLINICAL BLOOD GAS MIXTURE
- K991417 — ABL 735 ANALYZER
- K992834 — GEM PREMIER 3000
- K990092 — AVL OMNI MODULAR ANALYZER
- K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
- K984384 — 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
- K982277 — MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
- K980991 — NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
- K980523 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE
- K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
- K974526 — EASYBLOOD GAS ANALYZER
- K974396 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
- K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- K970710 — STAT PROFILE ULTRA M ANALYZER
- K963964 — AVL COMPACT 3 PH/BLOOD GAS ANALYZER
- K963800 — IL SYNTHESIS
- K961335 — GEM PREMIER PLUS MODEL 5500
- K961657 — CIBA CORNING 400 SYSTEM
- K962021 — CIBA CORNING 348 SYSTEM
- K961161 — AVL OPTI 1 PH/BLOOD GAS ANALYZER
- K955793 — IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
- K954482 — SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM
- K954711 — STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
- K953935 — MED-TECH CLINICAL BLOOD GAS
- K954612 — ABL SYSTEM 625, 615, 605
- K943882 — ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
- K936203 — STAT PROFILE PLUS 10 ANALYZER
- K946206 — CIBA CORNING 8-- SERIES CO-OXIMETER
- K945240 — IRMA BLOOD ANALYSIS SYSTEM
- K943643 — STAT PROFILE ULTRA 11 ANALYZER
- K944089 — AVL OPTI PH/BLOOD GAS ANALYZER
- K943570 — AVL COMPACT 1 PH/BLOOD GAS ANALYZER
- K942616 — AVL COMPACT 2 PH/BLOOD GAS ANALYZER
- K935121 — ABL SYSTEM 620
- K935655 — ABL5 BLOOD GAS SYSTEM
- K940918 — I-STAT 200 PORTABLE CLINICAL ANALYZER
- K935069 — IL1430 BGELECTROLYTE ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.