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Clinical Chemistry

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

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RecordFirmDate
RAI-TROL ELEVATED LIPIDS CONTROL (K915191)Reagents Applications, Inc.1991-12-18
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 (K915208)Medix Biotech, Inc.1991-12-18
TECHNICON CHEM 1 PLASMA GLUCOSE (K914794)Heraeus Kulzer, Inc.1991-12-18
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, (K915077)Beckman Instruments, Inc.1991-12-18
URIC ACID (URICASE) REAGENT, UNIVERSAL (K912028)Enzyme Technology, Inc.1991-12-18
PRECISE TM HCG (K915197)Becton Dickinson Advanced Diagnostics1991-12-17
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY (K914835)London Diagnostics, Inc.1991-12-17
PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA (K915200)Becton Dickinson Advanced Diagnostics1991-12-16
IMMUCHEM NEONATAL TSH-MP ELISA (K913963)Icn Biomedicals, Inc.1991-12-13
CREATINE KINASE MB TEST ITEM NUMBER 5A46 (K914361)Em Diagnostic Systems, Inc.1991-12-13
DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR (K914917)E.I. Dupont DE Nemours & Co., Inc.1991-12-13
CHROMATOGRAPHY CLINICAL USE 75JQR (K914841)Millipore Corp.1991-12-10
CEDIA T4 (K915194)Boehringer Mannheim Corp.1991-12-09
EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER (K914810)Medica Corp.1991-12-04
DIAZO COLORIMETRY, BILIRUBIN (K914873)Pointe Scientific, Inc.,1991-12-04
STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL (K914560)Ppg Industries, Inc.1991-11-29
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (K914511)Technicon Instruments Corp.1991-11-27
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT (K914906)Bio-Tek Instruments, Inc.1991-11-27
DIMENSION(R) LACTIC ACID METHOD (K914508)E.I. Dupont DE Nemours & Co., Inc.1991-11-27
REP(R) SPE TEMPLATE 30, 16, & 8 (K913807)Helena Laboratories1991-11-27
COULTER CARBON DIOXIDE REAGENT (K914486)Coulter Corp.1991-11-27
TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (K914888)Technicon Instruments Corp.1991-11-27
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR (K914750)Roche Diagnostic Systems, Inc.1991-11-22
CVM (K914619)Ciba Corning Diagnostics Corp.1991-11-22
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 (K914018)Em Diagnostic Systems, Inc.1991-11-22
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 (K913921)Em Diagnostic Systems, Inc.1991-11-22
TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) (K914025)Technicon Instruments Corp.1991-11-22
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 (K914464)Em Diagnostic Systems, Inc.1991-11-22
SR1 FREE T4 ENZYME IMMUNOASSAY (K912937)Serono-Baker Diagnostics, Inc.1991-11-19
CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY (K914510)Beckman Instruments, Inc.1991-11-19
TRACE GAMMA GT-SS REAGENT (K914731)Trace Scientific , Ltd.1991-11-19
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 (K914696)Medix Biotech, Inc.1991-11-13
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL (K913371)Creative Laboratory Products, Inc.1991-11-08
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST (K913357)Lifescan, Inc.1991-11-07
TRIGLYCERIDES REAGENT SET (K914609)Sterling Diagnostics, Inc.1991-11-07
OPUS(R) LH TEST SYSTEM (K913938)Pb Diagnostic Systems, Inc.1991-11-07
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 (K913764)Em Diagnostic Systems, Inc.1991-11-05
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 (K912807)Em Diagnostic Systems, Inc.1991-10-31
SODIUM REAGENT SET (K914039)Sterling Diagnostics, Inc.1991-10-31
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL (K914469)Cholestech Corp.1991-10-30
PHOSPHOLIPID REAGENT SET (K914040)Sterling Diagnostics, Inc.1991-10-30
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 (K913058)Helena Laboratories1991-10-30
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 (K913466)Em Diagnostic Systems, Inc.1991-10-25
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF (K914240)Unipath , Ltd.1991-10-25
CIBA CORNING ACS T3 IMMUNOASSAY (K913646)Ciba Corning Diagnostics Corp.1991-10-25
VENTREX COATED TUBE INTACT PTH (K913434)Ventrex Laboratories, Inc.1991-10-25
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (K913590)Dynatech Laboratories, Inc.1991-10-25
STAMBI-CK (K913349)Intl. Immunoassay Laboratories, Inc.1991-10-23
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (K914462)Serono-Baker Diagnostics, Inc.1991-10-23
LIPASE LINEARITY CONTROL (K913585)Creative Laboratory Products, Inc.1991-10-21
ABBOTT QUICKSTART LD-1,#5A30 (K914261)Em Diagnostic Systems, Inc.1991-10-21
QBC E-Z PREP (K913399)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-18
HOMECLINIC ONE STEP PREGNANCY TEST (K914254)Vanguard Biomedical Corp.1991-10-17
FIRST RESPONSE(R) ONE-STEP (K914304)Armkel, LLC1991-10-17
MARKSMAN ARTERIAL BLOOD GAS SYRINGE (K910970)Martech Medical Products, Inc.1991-10-15
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 (K913307)Em Diagnostic Systems, Inc.1991-10-11
URINE/CSF MICROPROTEIN REAGENT (K913225)Intersect Systems, Inc.1991-10-11
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST (K913927)Instrumentation Laboratory CO1991-10-11
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE (K914202)Baxter Diagnostics, Inc.1991-10-11
DIFF SAFE (K914129)Marshall Levinson1991-10-11
TARGET(TM)-HOG (K914303)V-Tech, Inc.1991-10-11
PROCLINIC ONE STEP PREGNANCY TEST (K914253)Vanguard Biomedical Corp.1991-10-11
ABBOTT QUICKSTART LDH,#5A31 (K914262)Em Diagnostic Systems, Inc.1991-10-11
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (K913025)Em Diagnostic Systems, Inc.1991-10-09
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE (K913978)Beckman Instruments, Inc.1991-10-09
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (K913705)Em Diagnostic Systems, Inc.1991-10-09
AFFINITY FREE T4 TEST SYSTEM (K912698)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-07
WELLPREP 1 (K913567)Denley Instruments, Inc.1991-10-04
YSI MODEL 2300 STAT PLUS (K913806)Ysis, Inc.1991-10-02
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST (K914068)Em Diagnostic Systems, Inc.1991-10-02
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 (K914069)Medical Analysis Systems, Inc.1991-10-02
AIA-PACK T-U (K913663)Tosoh Corp.1991-09-30
PROLACTIN IRMA IMMUNOMAG (K914107)Pantex, Div. Bio-Analysis, Inc.1991-09-30
MICROTAK PLUS (K913840)Syva Co.1991-09-30
MEDISENSOR 2001 (K903564)Medtest Systems, Inc.1991-09-30
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) (K913133)Bionostics, Inc.1991-09-27
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (K914033)Cholestech Corp.1991-09-27
AIA-PACK CK-MB (K913298)Tosoh Corp.1991-09-27
ENZYMUN-TEST ESTRADIOL (K913162)Boehringer Mannheim Corp.1991-09-27
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO (K912852)Baxter Healthcare Corp1991-09-27
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST (K912499)King Diagnostics, Inc.1991-09-27
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 (K913920)Em Diagnostic Systems, Inc.1991-09-27
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 (K913706)Em Diagnostic Systems, Inc.1991-09-27
STRATUS IINTELLECT IMMUNOASSAY SYSTEM (K913130)Baxter Healthcare Corp1991-09-27
J&S IRON REAGENTS (K912716)J.S. Medical Assoc.1991-09-25
LIPID LINEARITY CONTROLS (K913224)Creative Laboratory Products, Inc.1991-09-25
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES (K912616)Technicon Instruments Corp.1991-09-25
KODAK EKTACHEM DT SLIDES (LIPASE) (K913196)Eastman Kodak Company1991-09-25
QUANTIMETRIX AMMONIA CONTROLS (K913346)Quantimetrix Corp.1991-09-25
SELF-CONTAINED SURGICAL SLUSH FREEZER (K913777)Taylor Corp.1991-09-25
J&S UIBC REAGENTS (K912717)J.S. Medical Assoc.1991-09-25
RAICHEM(TM) CREATINE KINASE-MB REAGENT (K913398)Reagents Applications, Inc.1991-09-25
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL (K913792)Hichem Diagnostics1991-09-25
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B (K912749)Medical Analysis Systems, Inc.1991-09-23
ABBOTT QUICKSTART ALANINE AMINOTRANSFER (K913846)Em Diagnostic Systems, Inc.1991-09-19
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 (K913922)Em Diagnostic Systems, Inc.1991-09-19
CHEM-CHEX (K913687)Streck Laboratories, Inc.1991-09-19
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (K911912)Serono-Baker Diagnostics, Inc.1991-09-18
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 (K913707)Em Diagnostic Systems, Inc.1991-09-18
URINARY/CSF PROTEIN (K913615)Boehringer Mannheim Corp.1991-09-13
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