KHO

Malfunction

1,339

Total

1,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. Radiometer Medical Aps · 2012-01-20
• K973547 — TRIAGE STATMETER Biosite Incorporated · 1998-01-13
• K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Medics, Inc. · 1997-06-27
• K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM Johnson & Johnson Clinical Diagnostics, Inc. · 1996-10-18
• K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) Biocircuits Corp. · 1995-11-22
• K950415 — FLUOROSCAN NEONATAL Isolab, Inc. · 1995-09-05
• K935047 — AUTO DELFIA Wallac OY · 1994-05-23
• K930689 — AUTOBEAD THYROID UPTAKE Bio-Chem Laboratory Systems, Inc. · 1993-11-10
• K926131 — OPUS MAGNUM ANALYZER Pb Diagnostic Systems, Inc. · 1993-06-07
• K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Corp. · 1992-07-21
• K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 Dynatech Laboratories, Inc. · 1992-03-19
• K913130 — STRATUS IINTELLECT IMMUNOASSAY SYSTEM Baxter Healthcare Corp · 1991-09-27
• K901674 — AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Corp. · 1990-05-02
• K895240 — DELFIA PLATE FLUOROMETER 1232 Pharmacia, Inc. · 1989-10-04
• K894159 — OPUS IMMUNOASSAY SYSTEM Pb Diagnostic Systems, Inc. · 1989-08-03
• K890908 — STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES Baxter Healthcare Corp · 1989-03-24
• K872803 — CYBERFLUOR 615 IMMUNOANALYZER Cyberfluor, Inc. · 1987-09-02
• K871550 — PFI-20 POLARIZING FLUORIMETER The Perkin-Elmer Corp. · 1987-07-01
• K860309 — HEMAFLUOR REAGENT KIT Helena Laboratories · 1986-07-14
• K851984 — LKB-WALLAC 1230 ARCUS FLUOROMETER Lkb Instruments, Inc. · 1985-05-24
• K830624 — FLUOROMETER, GENERAL USE Abbott Diagnostics · 1983-04-05
• K822942 — INNOTRON FLUORIMETER SERIES ONE-10 Innotron of Oregon, Inc. · 1982-12-09
• K823112 — CLINISTAT TDA SERIES Miles Laboratories, Inc. · 1982-11-29
• K822772 — MICROFLUOR READER Dynatech Corp. · 1982-10-27
• K822701 — FLUOROSTAT FLUOROMETER Miles Laboratories, Inc. · 1982-10-08
• K813540 — A FLUOROMETER American Diagnostic Corp. · 1981-12-31
• K813146 — SYVA ADVANCE TM FLUOROMETER Syva Co. · 1981-11-27
• K811019 — LKB 4460 FLUORIMETER Lkb Instruments, Inc. · 1981-04-29
• K802579 — CYBREX TM FPQ FLUORESCENE POLARIZATION Abbott Laboratories · 1980-11-12
• K791329 — FLUOROMATIC ANALYZER AND AUTOSAMPLER Bio-Rad · 1979-07-30
• K790235 — SPECTROPHOTOMETER MODEL 3000 The Perkin-Elmer Corp. · 1979-03-15
• K790236 — SPECTROPHOTOMETER MODEL 650-40 The Perkin-Elmer Corp. · 1979-03-15
• K780242 — SPECTROPHOTOMETER, FLUORESCENCE M.650-10 The Perkin-Elmer Corp. · 1978-03-27
• K780362 — SPECTROFLUOROMETER SF-330 Varian Assoc., Inc. · 1978-03-22
• K780122 — HTSH RIA Abbott Laboratories · 1978-02-03
• K780031 — FLUORESCENCE DETECTOR MODEL 420 Waters Assoc., Inc. · 1978-01-20
• K760506 — HEMAFLOUR ZP Buchler Instruments, Inc. · 1976-10-28
• K760261 — DETECTOR, MODEL LC-100 FLUORESCENCE The Perkin-Elmer Corp. · 1976-09-27