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Clinical Chemistry

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

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RecordFirmDate
ROCHE REAGENTS REAGENT FOR CO2 (K844987)Roche Diagnostic Systems, Inc.1985-01-18
GLUCOSE(HEXOKINASE) REAGENT SET (K844998)Sterling Biochemical, Inc.1985-01-18
TDX TOTAL ESTRIOL (K844511)Abbott Laboratories1985-01-18
MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI (K844559)Thermo Orion1985-01-18
CLINIFACTS 10 DATA MANAGEMENT SYSTEM (K844907)Miles Laboratories, Inc.1985-01-18
BAKER CKMB REAGENT SET (K845024)Hybritech, Inc.1985-01-18
AVL MODEL 982 ELECTROLYTE ANALYZER (K844587)Avl Scientific Corp.1985-01-18
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K845027)Eastman Kodak Company1985-01-18
COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH (K844066)Clinetics Corp.1985-01-18
ROCHE REAGENTS REAGENT FOR URIC ACID (K844986)Roche Diagnostic Systems, Inc.1985-01-18
FOCUS UREA NITROGEN (K844755)Abbott Laboratories1985-01-08
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN (K844125)Bio-Rad1985-01-08
UROCYSTIN (K843382)Mission Pharmacal Co.1985-01-08
ALT/GPT REAGENT SET (K844251)Sterling Biochemical, Inc.1985-01-08
UROL-QUAL (K844760)Dimension Diagnostics1985-01-08
DATA-CHEM MAGNESIUM (K844278)Data Medical Associates, Inc.1985-01-08
MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 (K844806)Horiba Instruments, Inc.1985-01-08
CRITIC-ARS (K844709)Dimension Diagnostics1985-01-08
EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (K844710)Logos Scientific, Inc.1985-01-07
ALBUMIN BCP (K844426)Boehringer Mannheim Corp.1985-01-07
EPPENDORF DILUTER (K844798)Medical Technomics, Ltd.1985-01-07
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE (K844655)Boehringer Mannheim Corp.1985-01-07
GEMCAL ENI REFERENCE SERUM (K844344)Biocell Laboratories, Inc.1985-01-03
CALCIUM REAGENT FOR DEMAND ANALYZER (K844241)Advanced Biomedical Methods, Inc.1985-01-03
RAICHEM PHOSPHORUS REAGENT (K844316)Reagents Applications, Inc.1985-01-03
CREATININE REAGENT FOR DEMAND ANALYZER (K844332)Advanced Biomedical Methods, Inc.1985-01-03
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER (K844331)Advanced Biomedical Methods, Inc.1985-01-03
TOTAL BILIRUBIN FOR DEMAND ANALYZER (K844243)Advanced Biomedical Methods, Inc.1985-01-03
ALBUMIN REAGENT FOR DEMAND ANALYZER (K844330)Advanced Biomedical Methods, Inc.1985-01-03
AUTOLOADER II (K843779)Electro-Nucleonics Laboratories, Inc.1985-01-03
CHOLESTEROL REAGENT FOR DEMAND ANALYZER (K844242)Advanced Biomedical Methods, Inc.1985-01-03
UROPAPER EIKEN 7 (K843754)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN G (K843760)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN 5 (K843756)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN GK (K843758)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN AG (K843757)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN GP (K843753)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN 6B (K843755)Syn-Kit, Inc.1984-12-18
UROPAPER EIKEN HAG (K843759)Syn-Kit, Inc.1984-12-18
CONCEP-7-BHCG (EIA) (K844153)Leeco Diagnostics, Inc.1984-12-14
80 MG/DL GLUCOSE CONTROL (K844581)Boehringer Mannheim Corp.1984-12-12
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED (K844720)Data Medical Associates, Inc.1984-12-12
TRIGLYCERIDE CALIBRATOR (K844468)Sigma Diagnostics, Inc.1984-12-11
OVUSTICK SELF-TEST (K843284)Monoclonal Antibodies, Inc.1984-12-11
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS (K844586)Instrumentation Laboratory CO1984-12-11
WAKO AUTOMATED REAGENTS FOR HITACHI 705 (K842847)Wako Chemicals USA, Inc.1984-12-11
CORNING 614 NA/K ANALYZER (K843530)Corning Medical & Scientific1984-12-11
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED (K844408)Amersham Corp.1984-12-11
REFERRIL CALIBRATORS (K844585)Instrumentation Laboratory CO1984-12-11
REACTIFS, IBF ULTROGELS ACA & ULTROGELS A (K844164)Lkb Instruments, Inc.1984-12-10
SANDARE ALKALINE PHOSPHATASE PROCEDURE (K844498)Sandare Chemical Co., Inc.1984-12-10
ABL300 ACID BASE LABORATORY (K844295)Radiometer America, Inc.1984-12-10
ISE REAGENTS FOR DEMAND ANALYZER (K844021)Advanced Biomedical Methods, Inc.1984-12-10
PTK HEALTHCHECK PREGNANCY TEST KIT (K844281)Healthcheck Corp.1984-12-10
COAT-A-COUNT ANDROSTENEDIONE RIA KIT (K844398)Diagnostic Products Corp.1984-12-10
ENI BLOOD UREA NITROGEN REAGENT (K844065)Electro-Nucleonics Laboratories, Inc.1984-11-27
SERACON TM SR III (K844027)Bhp Diagnostix, Inc.1984-11-27
ULTRA LYTE POTASSIUM REAGENT KIT (K843454)Ultra Quest Diagnostics, Inc.1984-11-27
ACTH RIA (K844181)Syncor Intl. Corp.1984-11-27
ENZYME IMMUNOASSAY FOR DETECTION HORM (K841545)Btc Diagnostics, Inc.1984-11-27
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER (K844044)Medica Corp.1984-11-27
ULTRA LYTE SODIUM REAGENT KIT (K843453)Ultra Quest Diagnostics, Inc.1984-11-27
COBAS FLUORESCENCE POLARIZATION MODULE (K843914)Roche Diagnostic Systems, Inc.1984-11-27
SGOT REAGENT SET (K844322)Livonia Diagnostics, Inc.1984-11-27
TRIGLYCERIDES REAGENT SYSTEM (K843832)Fermco Biochemics, Inc.1984-11-27
SGPT REAGENT SET (K844283)Livonia Diagnostics, Inc.1984-11-27
GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 (K844018)United Diagnostics, Inc.1984-11-27
STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 (K843986)United Diagnostics, Inc.1984-11-27
SERACON TM SR IV (K844026)Bhp Diagnostix, Inc.1984-11-27
ADD-1 (K844114)Abbott Laboratories1984-11-27
QUEST BETA HCG ENZYME IMMUNOASSAY KIT (K844082)Quidel Corp.1984-11-21
LIQUID CHROMATOGRAPH 400 (K843568)The Perkin-Elmer Corp.1984-11-20
AMYLASE REAGENT CS-726 (K844168)Fisher Scientific Co., LLC1984-11-20
ALKALINE PHOSPHATASE REAGENT SET (K844237)Livonia Diagnostics, Inc.1984-11-20
CHLORIDE STANDARD (K844235)Shaban Mfg. Co.1984-11-20
TANDEM - EPRL (K843804)Hybritech, Inc.1984-11-13
UREA NITROGEN REAGENT SET (K844156)Livonia Diagnostics, Inc.1984-11-13
TRIGLYCERIDE REAGENT (K844032)Sigma Diagnostics, Inc.1984-11-09
TITAN GEL ISO DOT LDH KIT (K842669)Helena Laboratories1984-11-09
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS (K844047)Fisher Diagnostics1984-11-09
INORGANIC PHOSPHORUS REAGENT SET (K844182)Livonia Diagnostics, Inc.1984-11-09
ROCHE REAGENT FOR AST (K843109)Roche Diagnostic Systems, Inc.1984-11-05
HDL PRECIPATATING REAGENT SET (K843894)Livonia Diagnostics, Inc.1984-11-02
ABBOTT HTSH EIA DIAGNOSTIC KIT (K843540)Abbott Laboratories1984-11-02
PHARMACIA B2-MICRO RIA (K842772)Pharmacia, Inc.1984-11-01
AO-10 AUTOMATED OSMOMETER (K843997)bioMerieux, Inc.1984-10-31
RAICHEM X-HBDH REAGENT (K843774)Reagents Applications, Inc.1984-10-31
PARATHYROID HORMONE C-TERMINAL RIA KIT (K843871)Diagnostic Products Corp.1984-10-30
PHOTOMETER 90IYS (K843668)Institute Virion , Ltd.1984-10-30
LINEAR ENZYMATIC URIC ACID SYSTEM (K843938)Simmler, Inc.1984-10-30
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I (K843930)Euro-Diagnostics BV1984-10-30
BETA QUIK V (K843795)Pacific Biotech, Inc.1984-10-30
PARATHYROID HORMONE MID-MOLECULE RIA-KIT (K843870)Diagnostic Products Corp.1984-10-30
TOTAL CALCIUM REAGENT SET (K843895)Livonia Diagnostics, Inc.1984-10-30
FOCUS URIC ACID (K844011)Abbott Laboratories1984-10-30
MAGNESIUM REAGENT SET (K843893)Livonia Diagnostics, Inc.1984-10-30
TDX REA CREATININE (K843916)Abbott Laboratories1984-10-30
URIC ACID REAGENT SET (K844075)Livonia Diagnostics, Inc.1984-10-30
CREATININE REAGENT SET (K844024)Livonia Diagnostics, Inc.1984-10-30
SOMATOMEDIN-C RADIOIMMUNOASSAY KIT (K841088)Nichols Institute Diagnostics1984-10-22
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