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Clinical Chemistry

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

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RecordFirmDate
PROLACTIN (125) RADIOIMMUNAOASSAY (K803273)Corning Medical & Scientific1981-01-16
'NO-BOIL' DUALCOUNT KIT (K810001)Diagnostic Products Corp.1981-01-16
SYRINGE FOR BLOOD SAMPLING (K803182)The University of Chicago1981-01-16
HUMAN GROWTH HORMONE-RADIOIMM. KIT (K803280)Immuno Nuclear Corp.1981-01-16
CREATINE KINASE REAGENT (K803301)Gilford Diagnostics1981-01-16
AUTOMATED ELECTROPHORESIS SYSTEM (K803281)Helena Laboratories1981-01-16
LUQUIZYME TRIGLYCERIDE REAGENT SET (K803297)Amresco, Inc.1981-01-16
AUTOMATED IMMUOCHEMISTRY SYSTEM (K803267)Beckman Instruments, Inc.1981-01-16
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT (K803296)Immunotech Corp.1981-01-16
LKB-WALLACE 1250 LUMINOMETER (K803131)Lkb Instruments, Inc.1981-01-15
T3 RIABEAD DIAGNOSTIC KIT (K803261)Abbott Laboratories1981-01-15
CORNING 760 FLUOROMETER/DENSITOMETER (K803240)Transidyne General Corp.1981-01-09
TRI-LEVEL RADIOASSAY CONTROL SERA (K803098)American Diagnostic Corp.1981-01-09
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT (K803216)Union Carbide Corp.1981-01-09
CARDIOZYME PLUS CK-TOTAL #65046 (K803169)Harleco1981-01-09
VITAMIN B12 (57CO) RADIOIMMUNOASSAY (K802220)Corning Medical & Scientific1981-01-09
PARAGON ELECTRO. CREATINE KINASE TEST KI (K802826)Beckman Instruments, Inc.1981-01-09
CARDIO ZYME PLUS CK-MB #65045 (K803168)Harleco1981-01-09
1-125 LABELED TRIIODOTHYRONINE(T3) (K803180)Pcl-Ria, Inc.1981-01-09
FLAME PHOTOMETRY REAGENTS (K803051)Laboratory Products, Inc.1981-01-09
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. (K803254)Beckman Instruments, Inc.1981-01-09
PARALLEL CHEMICAL ANALYZER (K803135)American Monitor Corp.1981-01-09
BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. (K802451)Syn-Kit, Inc.1981-01-09
AMES SERA-PAK ALBUMIN REAGENT KIT (K803237)Miles Laboratories, Inc.1981-01-09
TRIGLYCERIDES (UV)-2 REAGENTS (K803091)Reagents Applications, Inc.1981-01-09
MAGNESIUM TEST KIT (K803088)Mallinckrodt Critical Care1981-01-02
LEECO TESTO-QUANT DIAGNOSTIC KIT (K803001)Leeco Diagnostics, Inc.1981-01-02
CHLORIDE/TCO2 ANALYZER REAGENTS (K803013)Laboratory Products, Inc.1981-01-02
CORTISOL 125-I RADIOIMMUNOASSAY KIT (K802969)Ria Products, Inc.1981-01-02
GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (K803089)Environmental Chemical Specialties1981-01-02
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS (K803044)American Dade1981-01-02
LANCER CREATININE MICROSAMPLE STAT ANA (K803087)Sherwood Medical Co.1981-01-02
RIAPHASE (125I) PROST. ACID PHOSPH. KIT (K803043)Beckman Instruments, Inc.1981-01-02
IMMU-TRACE T4 RIA PROCEDURE (K803046)American Dade1981-01-02
THE BIO-TEK CHROMOSCAN (K803030)Bio-Tek Instruments, Inc.1980-12-22
HDL-CHOLESTEROL CONTROL SERUM (K802997)Isolab, Inc.1980-12-22
SERALYZER LDH REAGENT STRIPS, CALIBR (K803019)Miles Laboratories, Inc.1980-12-22
MIC-BIOPLATE INOCULATOR (K803092)Pasco Laboratories, Inc.1980-12-22
FOLATE 125I RADIOIMMUNOASSAY (K803060)Corning Medical & Scientific1980-12-22
CHEM-ASSAY STANDARD-CONTROLS (K802962)National Bio-Technical Laboratories1980-12-22
QUANTIMUNE E3 RIA (K802944)Bio-Rad1980-12-22
BETA-TEC QUALITATIVE (K802999)Armkel, LLC1980-12-22
AMINO ACID ANALYSER SYSTEM (K803004)Lkb Instruments, Inc.1980-12-22
RAPI-DOT (K802974)Organon, Inc.1980-12-19
NIKON URINE REFRACTOMER SG-1 (K802959)Nippon Kogaku, Inc.1980-12-19
T3-SQUIBB RIA KIT (K802883)E. R. Squibb & Sons, Inc.1980-12-19
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY (K802923)Beckman Instruments, Inc.1980-12-19
PACE-4-AUTOMATIC RIA GAMMA-COUTER (K802578)Philips Medical Systems (Cleveland), Inc.1980-12-18
SINGLE VIAL LIPASE TEST KIT (K802842)Biodynamics Corp.1980-12-18
PARAGON ELECTROPHORESIS LACTATE REAG.KIT (K802628)Beckman Instruments, Inc.1980-12-11
COMBUNED CALCIUM AND PHOSPHORUS STD. (K802824)Mallinckrodt Critical Care1980-12-11
125I-TESTOSTERONE TEST SET (K802728)Wien Laboratories, Inc.1980-12-11
BUN/GLUCOSE STANDARDS (K802633)Gilford Diagnostics1980-12-11
COMBINED GLUCOSE AND BUN STANDARDS (K802825)Mallinckrodt Critical Care1980-12-11
COMPU-CHEM II CHEMISTRY ANALYZER (K802835)Diagnostic Aids, Inc.1980-12-11
ALBUMIN/TOTAL PROTEIN STANDARDS (K802632)Gilford Diagnostics1980-12-11
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (K802725)Varian Assoc., Inc.1980-12-11
CREATININE STANDARDS (K802631)Gilford Diagnostics1980-12-11
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT (K802822)Beckman Instruments, Inc.1980-12-11
CHOLESTEROL STANDARDS (K802823)Mallinckrodt Critical Care1980-12-11
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT (K802661)Damon Corp.1980-12-10
OREIA-Q-TY, ENZYME IMMUNOASSAY (K802693)Organon, Inc.1980-12-10
CENTRIFICHEM COMB. SERUM-BASED CALIB. (K802741)Union Carbide Corp.1980-12-10
HEXOKINASE, GLUCOSE (K802810)Beckman Instruments, Inc.1980-12-10
AMES SERA-PAK URIC ACID REAGENT KIT (K802724)Miles Laboratories, Inc.1980-12-10
AMES SERA-PAK CHOLESTEROL REAGENT KIT (K802743)Miles Laboratories, Inc.1980-12-10
LANCER URIC ACID AUTO/STAT KIT (K802692)Sherwood Medical Co.1980-12-10
SPECIAL PROCEDURE AQAROSE FILM (K802395)Electrophoresis Corp.1980-11-26
GENERAL PROCEDURE AGAROSE FILM (K802396)Electrophoresis Corp. of America1980-11-26
CHEMISTRY ANALYZER IMPACT 400 (K802609)Gilford Instrument Laboratories, Inc.1980-11-26
CAFFEINE REAGENT DIAZO COLORIMETRY (K802630)American Monitor Corp.1980-11-26
ANSWER AT-HOME PREGNANCY TEST KIT (K802660)Armkel, LLC1980-11-24
SERUM T4 BY ENZYME IMMUNOASSAY (K802573)Worthington Diagnostic Systems1980-11-24
T4 RADIOIMMUNOASSAY KIT (K802469)American Diagnostic Corp.1980-11-12
LIQUID CHROMATOGRAPHY COLUMNS (K802703)Supelco, Inc.1980-11-12
BECKMAN LIQUID-STAT LD-L-UV ENZYME (K802572)Beckman Instruments, Inc.1980-11-12
CYBREX TM FPQ FLUORESCENE POLARIZATION (K802579)Abbott Laboratories1980-11-12
GESTE FOLLOW KIT DETERM. OF HPL (K802454)Syn-Kit, Inc.1980-11-12
PARAGON SERUM PROTEIN ELECTROPHORESIS (K802592)Beckman Instruments, Inc.1980-11-12
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY (K802581)Beckman Instruments, Inc.1980-11-12
CK-MB(IMMUNOLOGICAL) (K802521)Biodynamics Corp.1980-11-12
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO (K802574)Beckman Instruments, Inc.1980-11-12
BECKMAN DP-5500 DATA REDUCTION SYSTEM (K802594)Beckman Instruments, Inc.1980-11-12
BUN REAGENT ASTRA 4 & 8 ANALYZERS (K802518)Nobel Scientific Industries, Inc.1980-11-12
CENTRIFICHEM PIPETTOR ACCURACY CALIB. (K802520)Union Carbide Corp.1980-11-12
CHEMTROLER (K802471)Fletcher Flora Computer Products, Inc.1980-11-12
T3 RADIOIMMUNOASSAY KIT (K802470)American Diagnostic Corp.1980-11-12
CBC PAP TEST KIT (K802153)Calbiochem-Behring Corp.1980-11-12
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER (K802379)American Instrument Co.1980-10-31
GESTATE SLIDE EIKEN KIT AGG. METHOD HUM (K802450)Syn-Kit, Inc.1980-10-31
ELECTROLY TE CHEMISTRY ANALYZER (K802398)Instrumentation Laboratory CO1980-10-31
COULTER DACOS SERUM CHEM. ANALYZER (K802320)Coulter Electronics, Inc.1980-10-31
TSH RADIOIMMUNOASSAY KIT (K802467)American Diagnostic Corp.1980-10-31
CENTRIFICHEM INORGANIC PHOSPHORUS (K802420)Union Carbide Corp.1980-10-31
WASH SOLUTION KIT, #88102 (K802264)Hi Chem, Inc.1980-10-31
OREAI-Q-TU TEST (K802464)Organon, Inc.1980-10-31
ICA1 IONIZED CALCIUM ANALYZER (K801848)The London Co.1980-10-31
ESTRIOL-SQUIBB RIA KIT (K802455)E. R. Squibb & Sons, Inc.1980-10-31
T3 UPTAKE TEST SYSTEM (K802468)American Diagnostic Corp.1980-10-31
ARIA II 125 I CORTISOL (K802380)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-31
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