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Clinical Chemistry

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

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RecordFirmDate
AQUALITE INTACT PTH (K970483)Sealite Sciences, Inc.1997-04-14
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) (K970894)Johnson & Johnson Clinical Diagnostics, Inc.1997-04-14
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE (K971051)Diagnostic Products Corp.1997-04-10
CARDIOISOZYME, CK/LD ISOENZYME CONTROL (K970856)Medical Analysis Systems, Inc.1997-04-08
CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 (K970956)Chiron Diagnostics Corp.1997-04-08
SPINALSCOPICS (K970862)Quantimetrix Corp.1997-04-08
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER (K970227)Dpc Cirrus1997-04-08
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT (K962208)Nichols Institute Diagnostics1997-04-08
CLINISTRIP (K970250)Teco Diagnostics1997-04-08
ORGENTEC MICRO-ALBUMIN EIA ASSAY (K970932)American Laboratory Products Co., Ltd.1997-04-08
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) (K970921)Alko Diagnostic Corp.1997-04-08
CLINITEK HCG TEST STRIPS (K971209)Bayer Corp.1997-04-04
THE ELECSYS CALCHECK PROGESTERONE (K970984)Boehringer Mannheim Corp.1997-04-02
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) (K970701)Diagnostic Systems Laboratories, Inc.1997-04-02
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K970976)Medical Analysis Systems, Inc.1997-04-02
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 (K970979)Chiron Diagnostics Corp.1997-04-02
PARAMAX TRIGLYCERID REAGENT (K964346)Dade Intl., Inc.1997-03-28
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (K962687)Nichols Institute Diagnostics1997-03-28
MAGNESIUM (K964915)Derma Media Lab., Inc.1997-03-26
BILE ACIDS REAGENT SET (K970120)Teco Diagnostics1997-03-24
CHIRON DIAGNOSTICS ACS:180TU P (K970539)Chiron Diagnostics Corp.1997-03-24
AXSYM B12 (K965186)Abbott Laboratories1997-03-24
ELECSYS PROGESTERONE ASSAY (K964841)Boehringer Mannheim Corp.1997-03-24
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) (K970643)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT (K962408)Nichols Institute Diagnostics1997-03-18
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) (K965142)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
ELECSYS TESTOSTERONE ASSAY (K964889)Boehringer Mannheim Corp.1997-03-18
GENESIS RMP (K963268)Tecan U.S., Inc.1997-03-18
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT (K970467)Excel Scientific, Inc.1997-03-18
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN (K962723)Trace America, Inc.1997-03-13
URIC ACID (LIQUID) REAGENT SET (K970560)Pointe Scientific, Inc.,1997-03-11
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT (K965058)Nichols Institute Diagnostics1997-03-11
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (K970477)Sebia1997-03-10
EPISCREEN (K970357)Epitope, Inc.1997-03-10
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL (K970100)Simplicity Diagnostics, Inc.1997-03-10
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L (K965240)Beckman Instruments, Inc.1997-03-10
HUMAN CHORIONIC GONADOTROPIN METHOD (K970387)Dade Chemistry Systems, Inc.1997-03-10
ELECSYS CALCHECK CEA (K970459)Boehringer Mannheim Corp.1997-03-06
LIPASE REAGENT SET (COLIPASE METHOD) (K970124)Teco Diagnostics1997-03-06
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST (K970424)Excel Scientific, Inc.1997-03-06
CR PERFECT (K970087)Chimera Research & Chemical, Inc.1997-03-06
ELECSYS CALCHECK CEA (K970452)Boehringer Mannheim Corp.1997-03-06
ELECSYS CALCHECK PSA (K970458)Boehringer Mannheim Corp.1997-03-06
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST (K970425)Excel Scientific, Inc.1997-03-06
MMB CALIBRATOR (K970336)Dade Chemistry Systems, Inc.1997-03-03
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT (K964698)Andwin Scientific1997-03-03
ABBOTT HCG SERUM CONTROLS (K970527)Abbott Laboratories1997-03-03
SYNERMED ISE REAGENTS (K962479)Synermed, Inc.1997-03-03
THYROID STIMULATING HORMONE METHOD (K970393)Dade Chemistry Systems, Inc.1997-03-03
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (K970126)Bio-Rad Laboratories, Inc.1997-02-25
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
ACCUPACK PREGNANCY TEST (K964633)Genix Biotek, Inc.1997-02-20
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC (K965116)Abbott Laboratories1997-02-20
SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188)Sealite Sciences, Inc.1997-02-20
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) (K964982)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-20
IRON REAGENT (K964913)Derma Media Lab., Inc.1997-02-20
TUMOR MARKER CONTROL (K965114)Diagnostic Products Corp.1997-02-20
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (K970396)Dade Chemistry Systems, Inc.1997-02-20
SUPREME II METER (K963544)Chronimed, Inc.1997-02-20
PRECISION G BLOOD GLUCOSE TESTING SYSTEM (K963676)Medisense, Inc.1997-02-20
THE ADVANCED OSMOMETER (3900) (K965036)Advanced Instruments, Inc.1997-02-20
VITROS CHEMISTRY PRODUCTS UPRO SLIDES (K964960)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-18
STRATEC LIA II ANALYZER (K961142)Nichols Institute Diagnostics1997-02-18
OLYMPUS ACID PHOSPHATASE REAGENT (K963640)Olympus America, Inc.1997-02-18
ELECSYS ESTRADIOL ASSAY (K965109)Boehringer Mannheim Corp.1997-02-18
ADVANCED QUALITY PREGNANCY TEST (K970008)Bionike, Inc.1997-02-18
SAS PREGNANCY STRIP (K965253)Sascie1997-02-18
SAS SERUM/URINE HCG (K965250)Sascie1997-02-18
THYROID CALIBRATOR (K970389)Dade Chemistry Systems, Inc.1997-02-18
ALT/SGPT (K965134)Derma Media Lab., Inc.1997-02-18
MMB METHOD (K970343)Dade Chemistry Systems, Inc.1997-02-14
SEALITE SCIENCES AQUALITE FSH (K970085)Sealite Sciences, Inc.1997-02-14
ONE-STEP DIPSTICK PREGNANCY TEST (K964536)Teco Diagnostics1997-02-11
CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (K970248)Canyon Diagnostics, Inc.1997-02-11
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST (K964462)Teco Diagnostics1997-02-11
ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST (K964461)Teco Diagnostics1997-02-11
CARDIAC T TROPONIN T RAPID ASSAY (K964372)Boehringer Mannheim Corp.1997-02-10
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS (K964004)Bayer Corp.1997-02-10
ELECSYS CALCHECK PROLACTIN (K970147)Boehringer Mannheim Corp.1997-02-10
TROPONIN-I TEST SYSTEM (K964862)Dade Intl., Inc.1997-02-10
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT (K964010)Beckman Instruments, Inc.1997-02-10
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET (K965202)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-02-10
GLUCOMETER ELITE BLOOD GLUCOSE METER (K964630)Bayer Corp.1997-02-10
ELECSYS CALCHECK ESTRADIOL (K970148)Boehringer Mannheim Corp.1997-02-10
FEMEXAM TESTCARD (K962718)Litmus Concepts, Inc.1997-02-07
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) (K965169)Specialized Assays, Inc.1997-02-06
HCG CONTROLS (K970176)International Newtech Development, Inc.1997-02-06
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) (K965166)Specialized Assays, Inc.1997-02-04
ALKALINE PHOSPHATASE (K964914)Derma Media Lab., Inc.1997-02-04
OSOM CLASSIC HCG-URINE TEST (115) (K965227)Wyntek Diagnostics, Inc.1997-02-04
STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) (K965168)Specialized Assays, Inc.1997-02-04
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) (K964720)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-04
PERFECTA PREGNANCY TEST (K965184)Wyntek Diagnostics, Inc.1997-02-04
ELECSYS CALCHECK TESTOSTERONE (K970146)Boehringer Mannheim Corp.1997-01-30
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) (K970016)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-30
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) (K965048)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-27
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST (K970082)Abbott Laboratories1997-01-24
THE ROBOLITE (K964460)Shai Syg Motion and Innovations, Ltd.1997-01-24
OPUS BONE ALP (K964764)Behring Diagnostics, Inc.1997-01-24
MICRO H2 (K963376)Micro Direct, Inc.1997-01-24
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