Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
SERUM TOTAL PROTEIN REAGENT SET (K841069)Medical Specialties, Inc.1984-05-01
URIC ACID REAGENT SET ENZYMATIC (K841049)Medical Specialties, Inc.1984-05-01
CREATININE REAGENT SET (K841070)Medical Specialties, Inc.1984-05-01
TRIGLYCERIDE REAGENT SET (K841062)Medical Specialties, Inc.1984-05-01
LDH-UV REAGENT SET (K841058)Medical Specialties, Inc.1984-05-01
DIRECT GLUCOSE REAGENT SET (K841054)Medical Specialties, Inc.1984-05-01
SGPT REAGENT SET (K841060)Medical Specialties, Inc.1984-05-01
CHOLESTEROL REAGENT SET (K841052)Medical Specialties, Inc.1984-05-01
CHOLESTEROL REAGENT SET ENZYMATIC (K841053)Medical Specialties, Inc.1984-05-01
ALBUMIN REAGENT SET (K841063)Medical Specialties, Inc.1984-05-01
COATED TUBE HCG IMMUNOASSAY HCG (K841023)Ventrex Laboratories, Inc.1984-05-01
SGOT-UV REAGENT SET (K841066)Medical Specialties, Inc.1984-05-01
ALKALINE PHOSPHOTASE REAGENT SET (K841064)Medical Specialties, Inc.1984-05-01
URIC ACID REAGENT SET (K841067)Medical Specialties, Inc.1984-05-01
SGPT REAGENT SET (K841059)Medical Specialties, Inc.1984-05-01
GELSCAN SOFTWARE 2190 (K834490)Lkb Instruments, Inc.1984-05-01
TOTAL BILIRUBIN REAGENT SET (K841050)Medical Specialties, Inc.1984-05-01
GLUCOSE ENZYMATIC REAGENT SET (K841055)Medical Specialties, Inc.1984-05-01
UREA NITROGEN REAGENT SET (K841068)Medical Specialties, Inc.1984-05-01
PHOPHORUS REAGNET SET (K841061)Medical Specialties, Inc.1984-05-01
HDL PRECIPITANT REAGENT SET (K841056)Medical Specialties, Inc.1984-05-01
SERUM CALCIUM REAGENT SET (K841051)Medical Specialties, Inc.1984-05-01
BIOSURE (K840848)Helena Laboratories1984-05-01
SGOT REAGENT SET (K841065)Medical Specialties, Inc.1984-05-01
URINE ANALYZER SYSTEM (K840996)Kyoto Diagnostics, Inc.1984-05-01
PHASE II FREE T4 KIT (K840901)Medical & Scientific Designs, Inc.1984-04-25
TOTAL BILIRUBIN REAGENT (K840486)Somas Medical Industries, Inc.1984-04-25
PARAMAX CHLORIDE REAGENT (K841047)American Dade1984-04-19
PHASE II HCG KIT (K840328)Medical & Scientific Designs, Inc.1984-04-19
TRISACRYL GF 05 & TRISACRYL GF 2000 (K840985)Lkb Instruments, Inc.1984-04-19
LIQUID CHROMATOGRAPHIC DETECTOR LC-95 (K840977)The Perkin-Elmer Corp.1984-04-19
KYOTEST UGK (K840829)Kyoto Diagnostics, Inc.1984-04-19
HIGH SPEED DISPENSER (K840938)Micromedic Systems1984-04-19
PLUS URINE HCG ASSAY (K840738)Monoclonal Antibodies, Inc.1984-04-19
MATCHED COMPONENT SET RADIOIMMUNOASSAY (K841042)Cambridge Medical Technology1984-04-19
ENDAB ESTRIOL UNCONJUGATED (K840902)Immunotech Corp.1984-04-18
HYDROXYPROGESTERONE BY RIA 17A (K840886)Radioassay Systems Laboratories, Inc.1984-04-18
IMMPULSE T4 ASSAY REAGENTS (K840852)Paragon Diagnostics, Inc.1984-04-18
FREE T3 SOLID PHASE RADIOIMMUNOASSAY (K840959)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-04-18
RAICHEM CREATININE REAGENT (K840872)Reagents Applications, Inc.1984-04-18
EKTACHEM CLINICAL CHEM. SLIDES (K840880)Eastman Kodak Company1984-04-18
AMRESCO E2A REAGENT SET 0562 & 0626 (K840887)American Research Products Co.1984-04-18
BIOTIS ABNORMAL CLINICAL CHEM SERUM- (K840458)Otisville Biotech, Inc.1984-04-17
POTASSIUM CHLORIDE TABLETS (K840843)Bionostics, Inc.1984-04-17
ALCOHOL & AMMONIA CALIBRATOR II (K840772)American Dade1984-04-13
LACTATE REAGENT (K840778)American Dade1984-04-13
NORMAL CLINICAL CHEM. CONTROL SERUM- (K840457)Otisville Biotech, Inc.1984-04-13
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT (K833396)Serono Diagnostics, Inc.1984-04-13
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID (K834505)Quantimetrix Corp.1984-04-13
OVU STICK URINE HLH KIT (K840412)Monoclonal Antibodies, Inc.1984-04-13
ALCOHOL & AMMONIA CALIBRATOR I (K840771)American Dade1984-04-13
URIC ACID REAGENT (K840781)American Dade1984-04-13
ISOSTAT MICROBIAL TUBE PROCESSING (K840496)E.I. Dupont DE Nemours & Co., Inc.1984-04-13
PARAMAX TOTAL PROTEIN REAGENT TP (K845052)American Dade1984-04-13
ALBUMIN REAGENT (K840782)American Dade1984-04-13
CK/MB IMMUNO-ISOENZYME CONTROL SERUM (K840793)Seragen Diagnostics, Inc.1984-04-13
HDL EZ-TZ3 CHOLESTEROL REAGENT KIT (K840677)Preventive Diagnostics Corp.1984-04-13
NEONATAL BILIRUBIN REAGENT (K840779)American Dade1984-04-13
LABSYSTEMS UNISKAN (K841214)Labsystems, Inc.1984-04-13
PARAMAX MAGNESIUM REAGENT (K840784)American Dade1984-04-13
TRIGLYCERIDES REAGENT (K840780)American Dade1984-04-05
SMI DIGITRON (K840186)Scientific Manufacturing Industries1984-04-05
FLOW-PAC CPK REAGENT SET (K832977)American Research Products Co.1984-04-05
DIRECT BILIRUBIN REAGENT (K840777)American Dade1984-04-05
PARAMAX UREA NITROGEN REAGENT (K840785)American Dade1984-04-05
LIQUI-URA CHEMISTRY URINE CONTROLS (K840618)Biodiagnostic Intl1984-04-04
CARBON DIOXIDE CALIBRATOR I (K840774)American Dade1984-04-04
PARAMAX CHOLESTEROL REAGENT (K840776)American Dade1984-04-04
ASPARTATE AMINOTRANSFERASE REAGENT (K840706)American Dade1984-04-04
CATS-CLINICAL LAB COMPUTER SOFTWARE- (K840502)Precision Technology, Inc.1984-04-04
PROGRESS SELECTIVE DHEMISTRY ANALYZ (K840200)Kone Instruments, Inc.1984-04-04
CARBON DIOXIDE CALIBRATOR II (K840775)American Dade1984-04-04
PDC HDL EZ-SEP CHOLESTEROL REAGENT (K840676)Preventive Diagnostics Corp.1984-04-04
PARAMAX AMMONIA REAGENTT (K840770)American Dade1984-04-04
VENTREZYME T4 IMMUNOASSAY T4 (K840473)Vxr, Inc.1984-04-04
AMERLEX HUMAN PLACENTAL LACTOGEN (K840588)Amersham Corp.1984-04-04
B-NEOCEPT 30 (K840650)Organon, Inc.1984-04-04
ADRENOCORTICOTROPIC HORMONE TEST (K833934)Clinetics Corp.1984-04-04
REAGENTS & STANDARDS IL 501 NA/K (K840557)Shaban Mfg. Co.1984-04-04
PARAMAX ACID PHOSPHATASE REAGENT (K840661)American Dade1984-04-04
CARBON DIOXIDE REAGENT (K840773)American Dade1984-04-04
ACCULAB SUPPLIES CHEMICAL ANALYZERS (K840501)Precision Technology, Inc.1984-04-04
EKTACHEM CLINICAL CHEM. SLIDES (K840606)Eastman Kodak Company1984-04-04
PARATHYROID HORMONE ANALYSIS PRODUCT (K840379)Nichols Institute Diagnostics1984-04-04
CREATINE KINASE MB REAGENT (K840783)American Dade1984-04-04
IMMPULSE TBC ASSAY REAGENTS (K840853)Paragon Diagnostics, Inc.1984-04-01
MCS ALBUMIN REAGENT (K840291)Medilab Corp.1984-03-30
WESCOR 5500 VAPOR PRESSURE OSMOMETER (K834214)Wescor, Inc.1984-03-30
PARTIAL PRESS. ELECTRODE MEASUREMENT (K840468)Shaban Mfg. Co.1984-03-30
MCS TOTAL PROTEIN REAGENT (K840290)Medilab Corp.1984-03-30
DURAZYME CHOLESTEROL (K840368)American Monitor Corp.1984-03-30
SUPPLIES FOR INSTRUMENTATION LAB FLAME (K840530)Shaban Mfg. Co.1984-03-30
THYROXINE EMIA (K840241)Collaborative Research, Inc.1984-03-30
RIANEN ESTRIOL RADIOIMMUNOASSAY KIT (K840301)New England Nuclear1984-03-30
NML CORTISOL RIA (K840466)Nuclear Medical Laboratories, Inc.1984-03-30
HDL CHOLESTEROL AQUEOUS STANDARDS (K840220)Preventive Diagnostics Corp.1984-03-23
IMMOPHASE DTESTO RADIOIMMUNOASSAY- (K840187)Corning Medical & Scientific1984-03-23
TRIGLYCERIDE AQUEOUS STANDARDS (K840218)Preventive Diagnostics Corp.1984-03-23
HDL CHOLESTEROL CONTROLS-LEVELS (K840278)Preventive Diagnostics Corp.1984-03-23
COLLOID OSMOMETER 4400 (K834208)Wescor, Inc.1984-03-23
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