Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
DSL ACTIVE NON-EXTRACTION IGF-I IRMA (K961172)Diagnostic Systems Laboratories, Inc.1996-04-23
OPUS T3 CONTROLS (K961206)Behring Diagnostics, Inc.1996-04-23
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM (K944459)Boehringer Mannheim Corp.1996-04-17
WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (K932661)Whatman Specialty Products, Inc.1996-04-17
THYROCHEK ONE-STEP RAPID TSH ASSAY (K960195)Franklin Diagnostics, Inc.1996-04-15
CARBON DIOXIDE - DST (K960035)Trace America, Inc.1996-04-08
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY (K953971)Trace America, Inc.1996-04-05
ACTIVE LH IRMA (K961109)Diagnostic Systems Laboratories, Inc.1996-04-05
HICHEM GLUCOSE/HK REAGENT KIT (K960084)Hi Chem, Inc.1996-04-04
LIPID CONTROL (K960862)Medical Analysis Systems, Inc.1996-04-03
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS (K960378)Actimed Laboratories, Inc.1996-04-03
TRUE TRIGLYCERIDE (K960088)Diagnostic Chemicals , Ltd.1996-04-01
UNIMARK MIDSTREAM PREGNANCY TEST STICK (K960174)Biotech Atlantic, Inc.1996-04-01
HICHEM BUN/UREA REAGENT KIT (K960115)Elan Pharma, Inc.1996-03-29
ACCESS FREE T3 ASSAY (K960913)Bio-Rad Laboratories, Inc.1996-03-29
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY (K960274)Orgentec1996-03-29
VACUTAINER BRAND PLUS SERUM & SST TUBES (K960250)Becton Dickinson Vacutainer Systems1996-03-29
ACTIVE CROSSLAPS ELISA (K960171)Diagnostic Systems Laboratories, Inc.1996-03-28
900UDX URINE PATHOLOGY SYSTEM (K960054)Intl. Remote Imaging Systems1996-03-22
BEST PREGNANCY TEST (K953606)Ameritek, Inc.1996-03-22
LXN FRUCTOSAMINE TEST (K955629)Lxn Corp.1996-03-20
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) (K936240)Sudormed, Inc.1996-03-19
VIVASPIN 4 10,000 MW (K960298)Vivascience, Inc.1996-03-19
SELFCARE EARLY PREGNANCY TEST (K960436)Selfcare, Inc.1996-03-19
T-3 MICROWELL EIA MODEL 7013 (K960412)Biomerica, Inc.1996-03-19
PLATFORM ONESTEP PREGNANCY HOME TEST (K960117)Syntron Bioresearch, Inc.1996-03-19
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (K955353)Tcpi, Inc.1996-03-19
ALBUMIN (K955781)Derma Media Lab., Inc.1996-03-13
CALCIUM REAGENT (K955939)Derma Media Lab., Inc.1996-03-13
TOTAL BILIRUBIN REAGENT (K955940)Derma Media Lab., Inc.1996-03-13
PSA CONTROLS (K960154)Diagnostic Products Corp.1996-03-13
CREATININE REAGENT (K955938)Derma Media Lab., Inc.1996-03-12
TOTAL PROTEIN REAGENT (K955936)Derma Media Lab., Inc.1996-03-12
SYSCON TURMOR MARKER CONTROL (K955812)Scantibodies Laboratory, Inc.1996-03-12
INORGANIC PHOSPHORUS REAGENT (K955937)Derma Media Lab., Inc.1996-03-12
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (K954977)Teco Diagnostics1996-03-11
SYNERMED ENZYMATIC CO2 REAGENT KIT (K960793)Synermed, Inc.1996-03-11
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS (K960120)Nova Biomedical Corp.1996-03-11
ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS (K960085)Alko Diagnostic Corp.1996-03-11
AXSYM PROGESTERONE (K955025)Abbott Laboratories1996-03-07
DSL ACTIVE HUMAN GROWTH HORMONE ELISA (K960551)Diagnostic Systems Laboratories, Inc.1996-03-06
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST (K944458)Boehringer Mannheim Corp.1996-03-06
ACTIVE T3 RIA (K960550)Diagnostic Systems Laboratories, Inc.1996-03-06
SELFCARE EARLY PREGNANCY TEST (K955903)Cambridge Diagnostics Ireland, Ltd.1996-03-06
RNA MEDICAL HEMAT CONTROL (K955630)Bionostics, Inc.1996-03-01
IRON CALIBRATOR & CALIBRATION VERIFICATION SET (K955796)Data Medical Associates, Inc.1996-02-29
SERUM BICARBONATE/CARBON DIOXIDE (K955302)Data Medical Associates, Inc.1996-02-29
ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT (K955266)Boehringer Mannheim Italia Spa1996-02-29
DSL ACTIVE PROLACTIN IRMA (K960060)Diagnostic Systems Laboratories, Inc.1996-02-29
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 (K954840)Sigma Diagnostics, Inc.1996-02-28
EASYSTAT SODIUM/POTASSIUM ANALYZER (K955375)Medica Corp.1996-02-23
DSL AACTIVE DHEA EIA KIT (K955114)Diagnostic Systems Laboratories, Inc.1996-02-23
OPUS PROLACTIN CONTROLS (K955468)Behring Diagnostics, Inc.1996-02-23
EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER (K955374)Medica Corp.1996-02-23
URIC ACID CATALOGE# 220-93/94/97 (K955496)Diagnostic Chemicals , Ltd.1996-02-23
GLUCOCHEK POCKETLAB (K951457)Clinical Diagnostics, Inc.1996-02-22
N/T PROTEIN CONTROL SY/L, M AND H (K955858)Behring Diagnostics, Inc.1996-02-21
IMMULITE HGH (K955376)Diagnostic Products Corp.1996-02-16
IMMULITE ACTH (K960066)Diagnostic Products Corp.1996-02-16
TOTAL CO2 (K951221)Randox Laboratories, Ltd.1996-02-15
ACCU-CHEK ADVANTAGE TEST STRIPS (K954833)Boehringer Mannheim Corp.1996-02-15
SYSCON CONTROL ASSAYED & UNASSAYED (K954247)Scantibodies Laboratory, Inc.1996-02-14
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T (K955868)Boehringer Mannheim Corp.1996-02-14
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM (K955793)Instrumentation Laboratory CO1996-02-14
AIA-PACK CPR ASSAY (K951848)Tosoh Medics, Inc.1996-02-13
ROCHE REAGENT FOR GLUCOSE (K953847)Roche Diagnostic Systems, Inc.1996-02-13
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT (K955139)Olympus America, Inc.1996-02-12
VIDAS ESTRADIOL II (E2II) ASSAY (K955647)Biomerieux Vitek, Inc.1996-02-06
IMMULITE TOTAL TESTOSTERONE (K955870)Diagnostic Products Corp.1996-02-06
ACCESS PROGESTERONE ASSAY (K955769)Bio-Rad Laboratories, Inc.1996-02-05
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION (K955260)Nova Biomedical Corp.1996-02-02
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K955264)Nova Biomedical Corp.1996-02-02
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 (K955252)Nova Biomedical Corp.1996-02-02
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (K950481)Isolab, Inc.1996-02-01
OLYMPUS URIC ACID REAGENT (K955752)Olympus America, Inc.1996-01-31
ACCESS FOLATE ASSAY (MODIFICATION) (K955434)Beckman Coulter, Inc.1996-01-29
IL TEST ACID PHOSPHATASE (K943366)Instrumentation Laboratory CO1996-01-29
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) (K955438)Teco Diagnostics1996-01-29
PHENYLALANINE TEST KIT (K943547)Isolab, Inc.1996-01-26
OPUS TROPONIN I (K955284)Behring Diagnostics, Inc.1996-01-25
ROCHE COBAS INTEGRA REAGENT CASSETTES (K954992)Roche Diagnostic Systems, Inc.1996-01-25
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS (K952557)Sigma Diagnostics, Inc.1996-01-24
ACCESS VITAMIN B12 ASSAY (MODIFICATION) (K955436)Bio-Rad Laboratories, Inc.1996-01-24
RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K954332)Bayer Corp.1996-01-24
ACCESS TOTAL T3 ASSAY (MODIFICATION) (K955435)Bio-Rad Laboratories, Inc.1996-01-24
PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (K953077)Beckman Instruments, Inc.1996-01-05
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV (K954839)Sigma Diagnostics, Inc.1996-01-05
PYRILINKS-D ASSAY KIT (K952320)Metra Biosystems, Inc.1995-12-29
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY (K955390)Corning Nichols Diagnostics1995-12-29
BLOOD GAS MIXTURE (K954546)Liquid Technology Corp.1995-12-28
EUROTROL GAS - ISE CONTROL (K955340)Direct Solutions1995-12-26
CK-MB (NAC-ACT) (K951223)Randox Laboratories, Ltd.1995-12-26
IMMULITE SHBG (MODIFICATION) (K955440)Diagnostic Products Corp.1995-12-21
ROCHE CONTROL SERUM N (K954655)Roche Diagnostic Systems, Inc.1995-12-21
CEDIA T UPTAKE ASSAY (K954807)Boehringer Mannheim Corp.1995-12-21
ROCHE CONTROL SERUM P (K954656)Roche Diagnostic Systems, Inc.1995-12-21
MIT ONE STEP PREGNANCY TEST (K953486)3c Diagnostics, Inc.1995-12-21
TOTAL BILIRUBIN PROCEDURE (K955300)Data Medical Associates, Inc.1995-12-20
AMERLITE MAB FT4 ASSAY (K955097)Kodak Clinical Diagnostics, Ltd.1995-12-20
AIA-PACK CORT ASSAY (K954591)Tosoh Medics, Inc.1995-12-15
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