Helena Laboratories
FDA 510(k) medical device clearances.
Top product codes for Helena Laboratories
Recent clearances by Helena Laboratories
1–100 of 280- K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL
- K100103 — SPECIALTY ASSAYED CONTROL-2
- K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
- K050053 — HEMORAM/AGGRAM ANALYZER
- K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
- K023761 — PLATELETWORKS, MODELS PW-A, PW-C
- K022757 — SPIFE CK KIT, MODEL 3332, 3333
- K022455 — SPIFE LD-12 KIT, MODEL 3338
- K022333 — SPIFE LIPPOROTEIN-12, MODEL 3344
- K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
- K020625 — SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346
- K020467 — SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
- K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
- K013466 — SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
- K012723 — PLATELETWORKS
- K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT
- K003359 — COLOSCREEN-ES
- K000603 — SPIFE CHOLESTEROL PROFILE KIT
- K992971 — REP CHOLESTEROL PROFILE KIT
- K992199 — ACID HEMOGLOBIN KIT
- K990998 — POLYSLIT IFE KIT
- K982426 — SPIFE ALKALINE HEMOGLOBIN
- K982639 — SPIFE URINE IFE
- K980671 — COLOSCREEN-ES
- K980650 — REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL
- K974609 — REP CHOLESTEROL PROFILE CONTROL-II
- K973040 — SPIFE IFE-6
- K972274 — SPIFE
- K973316 — REP SPE VIS-60/40 KIT
- K962914 — REP 3 QUTO-FLUR CHOLESTEROL-30
- K964453 — REP 3 FLUR SPE-60 KIT
- K964471 — REP FLUR CHOLESTEROL-60 KIT
- K961908 — THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
- K960571 — RAPID ELECTROPHORESIS ANALYZER
- K952321 — PORCINE FACTOR VIII;C REAGENT
- K952667 — CHROM Z-HEPARIN, CAT. NO 5242
- K952668 — CHROM Z-F:VIII, CAT. NO. 5241
- K952666 — CHROM Z-PROTEIN C, CAT. NO. 5243
- K952669 — CHROM Z-PLASMINOGEN, CAT. NO. 5244
- K951943 — CHROM Z CHROMOGENIC ASSAYS
- K951820 — THROMBOPLASTIN-LI REAGENT
- K952252 — ADP REAGENT, MODIFIED
- K951497 — CASCASE 480 SNSLYZER
- K946274 — COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
- K950590 — REP CHOLESTEROL PROFILE CONTROL
- K950801 — CARDIO REP LD CONTROL - CAT NO. 3325
- K935169 — APTT-ES
- K941872 — SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
- K935162 — REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT
- K933086 — AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
- K941737 — SPECIALTY ASSAYED CONTROL-1
- K941860 — SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
- K940679 — REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222
- K940224 — CARDIO REP LD
- K940310 — HELENA THROMBOPLASTIN-MI REAGENT
- K933277 — COAGULATION A.R.P.
- K932442 — CARDIO REP RECOMBINANT CK ABNORMAL CONTROL
- K932768 — CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
- K931956 — CASCADE M, CAT. NO. 1710
- K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
- K930317 — REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
- K931465 — REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
- K931247 — TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067
- K931050 — CARDIO REP CK ISOENZYME KIT - 3310
- K930359 — CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
- K926222 — OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
- K925801 — REP E-Z CK-30 ISOENZYME KIT
- K924915 — SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479
- K923658 — REP IMMUNOFIX
- K921578 — TITAN GEL ALKALINE PHOSPHATASE (HR)
- K923317 — COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
- K923318 — COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
- K922053 — REP SPE PLUS (PONCEAU S) SYSTEM
- K920820 — MODIFICATION COLUMNMATE
- K922024 — REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175
- K921676 — COLUMNMATE II
- K921465 — CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
- K920927 — KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
- K921305 — GLYCO-TEK AFFINITY COLUMN KIT
- K921363 — CASCADE 480
- K920926 — KEMTROL SERUM CONTROL-ABNORMAL
- K920147 — THROMBIN CLOTTING TIME REAGENT
- K914949 — COAGULATION ARPR,CAT.NO.5185
- K915418 — ELLAGIC ACID APTT REAGENT
- K914946 — CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
- K913384 — COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
- K913807 — REP(R) SPE TEMPLATE 30, 16, & 8
- K913058 — REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
- K911777 — ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
- K912774 — ARACHIDONIC ACID
- K912201 — PACKS-4 (TM) ANALYZER
- K912603 — REP ALP-15, 8, & 4 KITS
- K912386 — REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
- K905798 — COLOCARE
- K911075 — COLOSCREEN
- K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367
- K910706 — COLLAGEN REAGENT CAT. NO. 5368
- K910800 — ADP REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.