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Clinical Chemistry

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

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RecordFirmDate
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S (K851308)Technicon Instruments Corp.1985-04-17
INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS (K850392)Clinical Data, Inc.1985-04-12
PHARMACIA INSULIN RIA (K851071)Pharmacia, Inc.1985-04-12
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO (K850574)American Dade1985-04-12
MEDIX VISUAL URINE HCG (7/7) TEST (K850949)Medix Biotech, Inc.1985-04-12
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT (K851104)Amersham Corp.1985-04-10
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3 (K851079)Beckman Instruments, Inc.1985-04-10
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H (K850575)American Dade1985-04-10
PRECO PREGNANCY RAPID CARD TEST, HEM #2028 (K850604)Preco, Inc.1985-04-08
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN (K850999)Technicon Instruments Corp.1985-04-08
DATA ZYME CO2 PROCEDURE (K850903)Data Medical Associates, Inc.1985-04-08
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM (K850987)Medix Biotech, Inc.1985-04-08
BACI 6 -ADRENOCORTICOTROOP HORMONE (K850053)Euro-Diagnostics BV1985-04-08
ABBOTT TDT EIA (K843908)Abbott Laboratories1985-04-03
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT (K850254)Cambridge Medical Technology1985-04-03
I-L TEST, DIRECT BILIRUBIN SET (K850748)Allied Instrumentation Laboratory1985-04-03
LEECO CONCEP-7-BHCG EIA (K850531)Leeco Diagnostics, Inc.1985-04-02
LEECO CONCEP-7-BHCG IRMA (K850530)Leeco Diagnostics, Inc.1985-04-02
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K850570)American Dade1985-04-02
MODEL SERUM HCG ASSAY (K850730)Monoclonal Antibodies, Inc.1985-04-02
DROPSTIRS - PLASTIC DISPOSABLE PIPET (K850800)Berwick Medical Products, Inc.1985-04-02
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE (K850986)Data Medical Associates, Inc.1985-04-01
CALIBRATOR B 88133 (K850405)Hi Chem, Inc.1985-04-01
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE (K850901)Data Medical Associates, Inc.1985-04-01
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER (K850659)Syva Co.1985-04-01
URI-VAL (K843680)Cenogenics Corp.1985-03-29
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI (K850054)E.I. Dupont DE Nemours & Co., Inc.1985-03-29
ISOENZYME TEST LD-1 (K850210)Sclavo, Inc.1985-03-29
SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (K850787)Nms Pharmaceuticals, Inc.1985-03-26
DUPONT PREP TYPE SI EXTRACITON CARTRIDGE (K850963)E.I. Dupont DE Nemours & Co., Inc.1985-03-25
CUE FERTILITY MONITOR (K850579)Zetek, Inc.1985-03-22
ACTH II BY RADIOIMMUNOASSAY (K850882)Immuno Nuclear Corp.1985-03-21
TITERTEK MULTISKAN MSS/340 (K844419)Flow Laboratories, Inc.1985-03-21
TITERTEK MULTISKAN MCC (K844418)Flow Laboratories, Inc.1985-03-21
TITERTEK TWINREADER 78-630-00 (K844567)Flow Laboratories, Inc.1985-03-21
BUN (RATE) REAGENT (K850923)Sigma Diagnostics, Inc.1985-03-20
DATA ZYME ACID PHOSPHATASE PROCEDURE (K850902)Data Medical Associates, Inc.1985-03-20
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & (K844955)Miles Laboratories, Inc.1985-03-19
GLUTAMYLTRANSFERASE ASSAY KIT (K850788)Diagnostic Chemicals, Ltd. (Usa)1985-03-19
AMYLASE PRODUCTS (K850798)Data Medical Associates, Inc.1985-03-14
SPECTRONIC 2000 SPECTROPHOTOMETER (K850767)Bausch & Lomb, Inc.1985-03-14
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS (K850334)Roche Diagnostic Systems, Inc.1985-03-14
SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER (K850709)Bausch & Lomb, Inc.1985-03-12
CORNING 780 FLUOROMETER/DENSITOMETER (K850617)Corning Medical & Scientific1985-03-12
ROTOR SYSTEMS A/S-400 & LA/S-400 (K850485)E.I. Dupont DE Nemours & Co., Inc.1985-03-12
UROTRON RL9 (K850348)Boehringer Mannheim Corp.1985-03-12
SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER (K850708)Bausch & Lomb, Inc.1985-03-11
PERIDOCHROM TRIGLYCERIDES GPO (K850667)Boehringer Mannheim Corp.1985-03-11
WATERS 740 DATA MODULE-PLOTTER INTEGRATOR (K850272)Millipore Corp.1985-03-06
PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU (K844135)Immuno Nuclear Corp.1985-03-05
TSH-STAT (K844583)Nuclear Medical Laboratories, Inc.1985-03-05
ENZYMATIC ALPHA-AMYLASE REAGENT KIT (K850639)Bio-Analytics Laboratories, Inc.1985-03-05
PRECINORM H & PRECIPATH H (K850017)Boehringer Mannheim Corp.1985-03-05
ISOCONTROL SERUM CK-MB (K850213)Sclavo, Inc.1985-03-05
OVU STICK SELF-TEST -MODIFICATION (K850480)Monoclonal Antibodies, Inc.1985-03-05
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG (K850079)Bioclinical Systems, Inc.1985-03-05
GLUCOSE - TRINDER- REAGENT (K850364)Sigma Chemical Co.1985-03-05
LEUCINE AMINOPEPTIDASE REAGENT (K844965)Alladin Diagnostic, Inc.1985-03-05
WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D (K850359)Millipore Corp.1985-03-05
BCS GLUCOSE COLORIMETRIC TEST (K850257)Bioclinical Systems, Inc.1985-03-05
LEECO CONCEP-7-BHCG LEIAD II (K850201)Leeco Diagnostics, Inc.1985-03-04
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT (K850159)Hybritech, Inc.1985-03-04
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES (K844346)Fisher Diagnostics1985-03-04
TERUMO SENSIBEAD EIA TSH KIT (K850376)Terumo Medical Corp.1985-03-04
DIRECT BILIRUBIN FOR DEMAND ANALYZER (K850379)Advanced Biomedical Methods, Inc.1985-03-01
OSMOLARITY STANDARDS (K844589)Rna Medical Corp.1985-03-01
PRL QUIK RIA KIT (K850383)Pacific Biotech, Inc.1985-03-01
MAGNESIUM REAGENT FOR DEMAND ANALYZER (K850381)Advanced Biomedical Methods, Inc.1985-03-01
IMA-TROL IMMUNOASSAY CONTROL (K844848)Dimension Diagnostics1985-03-01
LDH REAGENT FOR DEMAND ANALYZER (K850378)Advanced Biomedical Methods, Inc.1985-03-01
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER (K850380)Advanced Biomedical Methods, Inc.1985-03-01
QUICK-LYTE (K850209)Seragen Diagnostics, Inc.1985-02-27
ROCHE STANDARDS FOR CHLORIDE & CO2 (K850396)Roche Diagnostic Systems, Inc.1985-02-27
ULTROSER G (K844413)Lkb Instruments, Inc.1985-02-27
GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER (K850260)Gelman Sciences, Inc.1985-02-27
COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS (K844423)Diagnostic Products Corp.1985-02-27
SYVA SAMPLE SEAL (K844949)Syva Co.1985-02-15
GLUCOCHEK III (K842474)Larken Industries, Inc.1985-02-12
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN (K844914)Abbott Laboratories1985-02-12
ENZYGNOST LIPASE TEST (K844240)Behring Diagnostics, Inc.1985-02-12
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT (K850319)Sigma Diagnostics, Inc.1985-02-12
BCS POTASSIUM TURBIDIMETRIC TEST (K850258)Bioclinical Systems, Inc.1985-02-07
EPICHROME PAP (K844968)Cetus Corp.1985-02-07
ISOCONTROL SERUM LD- (K850211)Sclavo, Inc.1985-02-07
ISOENZYME TEST CK-MB (K850212)Sclavo, Inc.1985-02-07
CALCIUM (K850281)Boehringer Mannheim Corp.1985-02-06
ACTIVE CORTISOL DSL 2000-SP (K850141)Diagnostic Systems Laboratories, Inc.1985-02-06
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT (K850056)Leeco Diagnostics, Inc.1985-02-06
PARAGON TRICHECK ELECTROPHORESIS CONTROL (K844996)Beckman Instruments, Inc.1985-02-06
GELMAN TRIPHOR CONTROL (K850202)Gelman Sciences, Inc.1985-02-06
CORNING CALCIUM PH ANALYZER 634 (K844188)Corning Medical & Scientific1985-02-04
VISION TRIGLYCERIDES (K850031)Abbott Laboratories1985-02-04
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB (K844781)Shaban Mfg. Co.1985-02-01
SYSTE MATE TIBC HEM NO. 67225 (K850128)Em Diagnostic Systems, Inc.1985-02-01
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (K844767)Biotecx Laboratories, Inc.1985-02-01
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE (K845026)Amersham Corp.1985-02-01
SOPHEIA/MP CORTISOL EIA KIT (K850008)Diagnostic Products Corp.1985-02-01
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE (K850110)Abbott Laboratories1985-01-29
SYSTE MATE IRON, HEM NO. 67224 (K845020)Em Diagnostic Systems, Inc.1985-01-28
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT (K844347)Fisher Diagnostics1985-01-23
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