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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ABBOTT TDX/TDXFLX TT4 (K925109)Abbott Laboratories1993-01-04
UREA NITROGEN TEST (K925002)Em Diagnostic Systems, Inc.1993-01-04
OLYMPUS CREATINE KINASE REAGENT (K924832)Olympus Corp.1993-01-04
OLYUMPUS TOTAL PROTEIN REAGENT (K924659)Olympus Corp.1992-12-29
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET (K924862)Tosoh Medics, Inc.1992-12-28
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT (K925436)Medix Biotech, Inc.1992-12-28
CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 (K926015)Cala Diagnostics1992-12-28
REP E-Z CK-30 ISOENZYME KIT (K925801)Helena Laboratories1992-12-28
BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE (K925132)Becton Dickinson Advanced Diagnostics1992-12-28
CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM (K925668)E.I. Dupont DE Nemours & Co., Inc.1992-12-28
CIBA CORNING ACS T UPTAKE IMMUNOASSAY (K925257)Ciba Corning Diagnostics Corp.1992-12-28
VACUPLUS TUBES WITH BRICK RED STOPPERS (K924365)Starplex Scientific, Inc.1992-12-28
ELECTROPHORESIS TANK (K924020)The Binding Site, Ltd.1992-12-28
GLUCOSE TEST SYSTEM (K923587)Polymer Technology Corp.1992-12-28
CONCEIVE ONE-STEP PREGNANCY TEST (K925096)Quidel Corp.1992-12-28
ALBUMIN TEST (K923959)Em Diagnostic Systems, Inc.1992-12-28
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET (K924853)Tosoh Medics, Inc.1992-12-28
HCG STAT-PAK (K923925)Chembio Diagnostic Systems, Inc.1992-12-24
UNI-CHECK REAGENT STRIP (K924398)Diagnostic Solutions, Inc.1992-12-23
NICHOLS APO B CHEMILUMINESCENCE ASSAY (K925702)Nichols Institute Diagnostics1992-12-23
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 (K924915)Helena Laboratories1992-12-18
OLYMPUS IRON REAGENT (K924691)Olympus Corp.1992-12-18
ELITE TEST STRIPS GLUCOMETER (K924499)Heraeus Kulzer, Inc.1992-12-17
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 (K925151)Bio-Rad1992-12-17
OLYMPUS CHLORIDE REAGENT (K925338)Olympus Corp.1992-12-11
WATERS(TM) 996 PDA (K924347)Millipore Corp.1992-12-11
LYRIS 100/120 LABORATORY INFORMATION SYSTEM (K923844)Biovation, Inc.1992-12-11
ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE (K923879)Diagnostic Products Corp.1992-12-07
SYNERMED ENZYMATIC CO2 REAGENT KIT (K924428)Synermed, Inc.1992-12-03
OLYMPUS GLUCOSE REAGENT (K924601)Olympus Corp.1992-12-03
ALKALINE PHOSPHATASE KIT (K923507)Randox Laboratories, Ltd.1992-12-03
FIAGEN PROGESTERONE (K923410)Cyberfluor, Inc.1992-12-03
DMI BLOOD GAS ANALYZER/CARTRIDGE (K924758)Diamond Medical, Inc.1992-12-03
BICARBONATE (K924711)Em Diagnostic Systems, Inc.1992-12-03
GAMMA-GT (K923509)Randox Laboratories, Ltd.1992-12-03
ONE TOUCH TEST STRIPS (K923544)Lifescan, Inc.1992-12-03
QUICKVUE ONE-STEP HCG TEST (K925435)Quidel Corp.1992-12-03
OLYMPUS TOTAL BILIRUBIN REAGENT (K924964)Olympus Corp.1992-12-03
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (K924257)Serono-Baker Diagnostics, Inc.1992-11-30
VIDAS FREE THYROXINE(FT4) ASSAY (K925177)Biomerieux Vitek, Inc.1992-11-30
DELFIA HTSH ULTRA KIT (K923401)Wallac OY1992-11-30
OLYMPUS DIRECT BILIRUBIN REAGENT (K924963)Olympus Corp.1992-11-30
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 (K925203)Heraeus Kulzer, Inc.1992-11-25
OLYMPUS BUN REAGENT (K924693)Olympus Corp.1992-11-25
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 (K924259)Medix Biotech, Inc.1992-11-25
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 (K924572)Em Diagnostic Systems, Inc.1992-11-25
SYNCHRON TOTAL PROTEIN TEST --MODIFIED (K922467)Beckman Instruments, Inc.1992-11-23
OLYMPUS INORGANIC PHOSPHORUS REAGENT (K925057)Olympus Corp.1992-11-19
ROCHE REAGENT FOR GGT (K924246)Roche Diagnostic Systems, Inc.1992-11-18
OLYMPUS CHOLESTEROL REAGENT (K922231)Olympus Corp.1992-11-18
OLYMPUS ALKALINE PHOSPHATASE REAGENT (K925156)Olympus Corp.1992-11-18
TSH - THIRD GENERATION LOW CONTROLS (K924675)Nichols Institute1992-11-18
LUMICO ANALYZER SA-300 (K923158)Maruzen Petrochemical Co., Ltd.1992-11-17
BERTHOLD LB 954 (K922329)Eg&G Berthold Analytical Instruments, Inc.1992-11-16
ALT (GPT) - ALANINE AMINOTRANSFERASE (K923510)Randox Laboratories, Ltd.1992-11-16
MULTIDRAW SYSTEM (K922858)Cambridge Multi-Draw, Inc.1992-11-16
AST (GOT) - ASPARTATE AMINOTRANSFERASE (K923505)Randox Laboratories, Ltd.1992-11-16
OLYMPUS LACTATE DEHYDROGENASE REAGENT (K924965)Olympus Corp.1992-11-16
LB 9502- CLINILUMAT, LB 953 - AUTO-CLIMILUMAT (K922976)Eg&G Berthold Analytical Instruments, Inc.1992-11-16
VISTA FREE THYROXINE ASSAY (K923572)Syva Co.1992-11-16
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET (K924863)Tosoh Medics, Inc.1992-11-16
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET (K924854)Tosoh Medics, Inc.1992-11-16
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET (K924855)Tosoh Medics, Inc.1992-11-16
STATPAL II BLOOD GAS ANALYSIS SYSTEM (K922631)Ppg Industries, Inc.1992-11-10
EMDS ALKALINE PHOSPHATASE (ALP) TEST (K924574)Em Diagnostic Systems, Inc.1992-11-09
SYNERMED HDL CHOLESTLEROL REAGENT KIT (K924427)Synermed, Inc.1992-11-09
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) (K924471)Eastman Kodak Company1992-11-06
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST (K924573)Em Diagnostic Systems, Inc.1992-11-06
NOVA 13 ANALYZER, MODIFICATION (K924864)Nova Biomedical Corp.1992-11-06
NOVA 12 ANALYZER, MODIFICATION (K924743)Nova Biomedical Corp.1992-11-06
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET (K923821)Casco Standards1992-11-05
DOCUMENT CHEM III CALIBRATION VERIFICATION TEST (K923793)Casco Standards1992-11-05
DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET (K923795)Casco Standards1992-11-05
WELLWASH 4 MARK II (K922803)Denley Instruments, Inc.1992-11-05
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET (K923794)Casco Standards1992-11-05
KING DIAGNOSTICS GLUCOSE (HK) REAGENT (K923129)King Diagnostics, Inc.1992-11-02
I-STAT(TM) LEVELS 1,2,3 CONTROLS (K921477)I-Stat Corp.1992-11-02
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC (K924694)Olympus Corp.1992-10-28
IL TEST APOLIPOPROTEIN A1 (K923087)Instrumentation Laboratory CO1992-10-26
IL TEST AST, PN 35312 (K923641)Instrumentation Laboratory CO1992-10-26
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED (K924074)Baxter Diagnostics, Inc.1992-10-26
KODAK AMERLITE MAB FT3 ASSAY (K922713)Eastman Kodak Company1992-10-26
IL TEST APOLIPOROTEIN B (APO B) (K923080)Instrumentation Laboratory CO1992-10-26
CHOLESTEROL TEST (K923733)Em Diagnostic Systems, Inc.1992-10-26
ROCHE REAGENT FOR ALT (K924245)Roche Diagnostic Systems, Inc.1992-10-22
OLYMPUS CREATININE REAGENT (K924692)Olympus Corp.1992-10-19
OLYMPUS CALCIUM REAGENT (K924435)Olympus Corp.1992-10-19
OLYMPUS MAGNESIUM REAGENT (K924658)Olympus Corp.1992-10-19
OLYMPUS AMYLASE REAGENT (K924339)Olympus Corp.1992-10-19
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY (K922073)Baxter Diagnostics, Inc.1992-10-19
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 (K924599)Em Diagnostic Systems, Inc.1992-10-15
CK-NAC ACTIVATED KIT (K923511)Randox Laboratories, Ltd.1992-10-15
VISTA TRIIODOTHYRONINE ASSAY (K923571)Syva Co.1992-10-15
OPUS(R) CK-MB (K924429)Pb Diagnostic Systems, Inc.1992-10-15
KODAK AMERLEX MAB FT3 ASSAY (K922771)Eastman Kodak Company1992-10-14
REDI-CHECK PHOTMETER Q.A. (K923598)Awareness Technology, Inc.1992-10-14
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM (K923048)Boehringer Mannheim Corp.1992-10-14
TWO PART INORGANIC PHOSPHORUS TEST (K924470)Em Diagnostic Systems, Inc.1992-10-14
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD (K922945)Heraeus Kulzer, Inc.1992-10-14
KING DIAGNOSTICS UREA NITROGEN REAGENT (K922969)King Diagnostics, Inc.1992-10-13
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