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Clinical Chemistry

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

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RecordFirmDate
BIOTROL BICARBONATE (CO2) UV HP) (K874941)Biotrol, USA, Inc.1988-01-05
BLOOD UREA NITROGEN (K874532)Catachem, Inc.1988-01-05
REAGENT A AND REAGENT B (K874413)Seradyn, Inc.1988-01-05
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 (K874032)Diagnostic Products Corp.1987-12-30
LIQUI-SERA SPINAL FLUID CONTROL (K874459)Biodiagnostic Intl1987-12-29
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (K871835)Miles Laboratories, Inc.1987-12-22
HVA & HOMOVANILLIC ACID BY HPLC METHOD (K873372)Bio-Rad1987-12-22
WAKO(TM) AUTOKIT LIPASE (K874640)Wako Chemicals USA, Inc.1987-12-22
INORGANIC PHOSPHORUS (K874472)Catachem, Inc.1987-12-22
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) (K874658)Technicon Instruments Corp.1987-12-18
MULTICHEM CHLORIDE REAGENT S0933 (K874812)Simmler, Inc.1987-12-18
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY) (K874603)Ciba Corning Diagnostics Corp.1987-12-18
FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 (K874622)Cyberfluor, Inc.1987-12-18
LACTATE DEHYDROGENASE LDH-L (K874848)Tech-Co, Inc.1987-12-18
MAGNESIUM (K874847)Tech-Co, Inc.1987-12-18
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 (K874708)Em Diagnostic Systems, Inc.1987-12-18
IMACK-MB TEST PROCEDURE (MODIFICATION) (K874545)Intl. Immunoassay Laboratories, Inc.1987-12-18
PARAMAX MAGNESIUM REAGENT (K873530)Baxter Healthcare Corp1987-12-14
PARAMAX ISE CHLORIDE CALIBRATOR (K873743)Baxter Healthcare Corp1987-12-14
MULTI-FUNCTION BLOOD GAS CONTROL (K874408)Bionostics, Inc.1987-12-14
PARAMAX CALCIUM REAGENT (K873519)Baxter Healthcare Corp1987-12-14
MEDATRON CUVETTE DISC (K873656)Medatron, Inc.1987-12-14
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K874131)Pointe Scientific, Inc.,1987-12-04
ABBOTT PAP-EIA (K873903)Abbott Laboratories1987-12-01
LAD MODEL 735 LUMINOMETER (K874262)Los Alamos Diagnostics1987-11-27
MULTICHEM (R) TOTAL BILIRUBIN (K874311)Simmler, Inc.1987-11-25
IQ/QCA TOTAL BILIRUBIN (K874261)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-11-25
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 (K874476)Em Diagnostic Systems, Inc.1987-11-25
O.P.T.(TM) OVULATION PREDICTION TEST (K870584)Warner-Lambert Co.1987-11-25
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 (K874397)Em Diagnostic Systems, Inc.1987-11-24
TITAN GEL REP LDH-30 HV (K874142)Helena Laboratories1987-11-24
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (K873737)Cambridge Medical Technology1987-11-24
GLUCOSE-HK REAGENT (K873835)Intersect Systems, Inc.1987-11-24
TITAN GEL REP LDH-6 HV (K874145)Helena Laboratories1987-11-24
A-GENT LIQUID AMYLASE (K873944)Abbott Laboratories1987-11-23
OVUGEN SURETEST (K873534)Biogenex Laboratories1987-11-23
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS (K874163)Catachem, Inc.1987-11-23
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 (K873788)Pacific Biotech, Inc.1987-11-23
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 (K874477)Em Diagnostic Systems, Inc.1987-11-23
VENTRESCREEN, HCG URINE (K874258)Ventrex Laboratories, Inc.1987-11-23
PARAMAX URIC ACID REAGENT (K873456)Baxter Healthcare Corp1987-11-23
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) (K874299)Incstar Corp.1987-11-23
PARAMAX CREATININE REAGENT (K873531)Baxter Healthcare Corp1987-11-23
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY (K873945)Ciba Corning Diagnostics Corp.1987-11-23
PROTEIN STANDARD CALIBRATOR (K871755)Wako Chemicals USA, Inc.1987-11-23
PARAMAX UREA NITROGEN REAGENT (K873532)Baxter Healthcare Corp1987-11-23
TITAN GEL REP LDH-12 HV (K874143)Helena Laboratories1987-11-23
REFLOTRON BILIRUBIN (K872818)Boehringer Mannheim Corp.1987-11-23
PARAMAX AMYLASE REAGENT (K873520)Baxter Healthcare Corp1987-11-23
BICARBONATE (K874435)Boehringer Mannheim Corp.1987-11-23
PARAMAX PHOSPHORUS REAGENT (K873454)Baxter Healthcare Corp1987-11-23
TITAN GEL REP CPK-6 HV (K874144)Helena Laboratories1987-11-23
MODIFIED PARAMAX GLUCOSE REAGENT (K873936)Baxter Healthcare Corp1987-11-23
PRECINORM L (K874230)Boehringer Mannheim Corp.1987-11-23
WAKO(TM) FE C (K874263)Wako Chemicals USA, Inc.1987-11-23
THE EXTRACTOR(TM) (K873932)Molecular Biosystems, Inc.1987-11-20
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA (K873384)Helena Laboratories1987-11-20
EASY-TEST CREATININE (CREA) ITEM NO. 19009 (K874088)Em Diagnostic Systems, Inc.1987-11-06
WAKO(TM) AUTOKIT CK-NAC (K873201)Wako Chemicals USA, Inc.1987-11-05
AMERLITE TT4 ASSAY (240/480/144 TEST KITS) (K873976)Amersham Corp.1987-11-05
TITAN GEL REP CPK-12 HV (K874146)Helena Laboratories1987-11-05
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 (K874153)Em Diagnostic Systems, Inc.1987-11-04
TITAN GEL REP CPK/LDH ISOENZYME CONTROL (K874141)Helena Laboratories1987-11-04
PROJECT 300 MICROASSAY BP-12, EIA MINILAB (K873451)Awareness Technology, Inc.1987-11-04
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST (K874248)Syntron Bioresearch, Inc.1987-11-04
DART (R) ELECTROLYTE REAGENT SYSTEM (K874185)Coulter Electronics, Inc.1987-11-04
1205 BETAPLATE LIQUID SCINTILLATION COUNTER (K874094)Lkb Instruments, Inc.1987-11-04
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. (K874140)Helena Laboratories1987-11-03
DYNATECH MR 300 MANUAL MICROELISA (K874244)Dynatech Laboratories, Inc.1987-11-03
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 (K874061)Medix Biotech, Inc.1987-11-03
TITAN GEL REP CPK-30 HV (K874139)Helena Laboratories1987-11-03
AMERLITE TT3 ASSAY, LAN.0003/1003/2003 (K873858)Amersham Corp.1987-11-03
MULTICHEM ALBUMIN REAGENT S0902 (K874049)Simmler, Inc.1987-10-29
AFFINITY TOTAL THYROXINE IMMUNIT (K873518)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-29
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 (K873994)Em Diagnostic Systems, Inc.1987-10-29
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 (K873635)Em Diagnostic Systems, Inc.1987-10-29
MULTICHEM INORGANIC PHOSPHOROUS S0923 (K874038)Simmler, Inc.1987-10-28
HCG ENZYME IMMUNOASSAY TEST KIT CATALOG #MB-1013 (K873872)Medix Biotech, Inc.1987-10-28
SERALYZER III BLOOD CHEMISTRY ANALYZER (K872120)Miles Laboratories, Inc.1987-10-28
IRON REAGENT (K874055)Trace Scientific , Ltd.1987-10-28
GLUCOSE REAGENT KIT (K873128)A-Kem, Inc.1987-10-23
CREATININE REAGENT KIT (K873131)A-Kem, Inc.1987-10-23
CARBON DIOXIDE REAGENT KIT (K873129)A-Kem, Inc.1987-10-23
CHLORIDE REAGENT KIT (K873127)A-Kem, Inc.1987-10-23
BUN REAGENT KIT (K873132)A-Kem, Inc.1987-10-23
WASH SOLUTION KIT (K873130)A-Kem, Inc.1987-10-23
DHEA-S RIA KIT (K872879)Endocrine Associates, Inc.1987-10-23
SODIUM/POTASSIUM REAGENT KIT (K873126)A-Kem, Inc.1987-10-23
SODIUM AND POTASSIUM BY ION SELECTIVE (K873074)American Monitor Corp.1987-10-20
TITAN GEL CPK REP SYSTEM (K873399)Helena Laboratories1987-10-20
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS (K872505)Home Diagnostics, Inc.1987-10-20
RESULT PLUS/HCG PREGNANCY TEST (K872730)Ortho Diagnostic Systems, Inc.1987-10-20
IL 35260, IL TEST AMYLASE REAGENT (K873572)Instrumentation Laboratory CO1987-10-20
BILE ACIDS CONTROLS (K873342)Sigma Diagnostics, Inc.1987-10-20
TITAN GEL LDH REP SYSTEM (K873386)Helena Laboratories1987-10-20
STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY (K873051)American Dade1987-10-20
MULTICHEM CREATININE REAGENT S0917 (K873725)Simmler, Inc.1987-10-20
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL (K873250)Roche Diagnostic Systems, Inc.1987-10-20
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (K873431)Serono Diagnostics, Inc.1987-10-20
OSMOMETER MODEL 110 (K873642)Advanced Instruments, Inc.1987-10-20
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