Atlas FDA

Clinical Chemistry

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
TOX PERFECT B TUBES AND REAGENTS (K952501)Chimera Research & Chemical, Inc.1995-08-24
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY (K951321)Bio-Rad1995-08-24
ADVANTAGE TEST STRIPS (K951887)Boehringer Mannheim Corp.1995-08-24
OPUS T4 CONTROLS (K953097)Behring Diagnostics, Inc.1995-08-24
ALKPHASE-B ASSAY KIT (K952768)Metra Biosystems, Inc.1995-08-24
CONCEIVE OVULATION PREDICTOR (K953063)Quidel Corp.1995-08-23
OPUS B12 (K953455)Behring Diagnostics, Inc.1995-08-23
DMA TOTAL CHOLESTEROL PROCEDURE (K946161)Data Medical Associates, Inc.1995-08-23
SALIVA SAMPLER (K942435)Saliva Diagnostic Systems, Inc.1995-08-21
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS (K952180)Beckman Instruments, Inc.1995-08-17
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM (K952741)Medical Diagnostic Technologies, Inc.1995-08-17
CREATINE KINASE REAGENT SYSTEM (K952745)Medical Diagnostic Technologies, Inc.1995-08-11
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 (K951584)Sigma Diagnostics, Inc.1995-08-11
BLOOD UREA NITROGEN REAGENT SYSTEM (K952742)Medical Diagnostic Technologies, Inc.1995-08-11
DIA SCREEN REAGENT STRIPS (K952971)Genesis Labs, Inc.1995-08-11
DUPONT DIMENSION TOTAL PROTEIN METHOD (K950920)Dupont Medical Products1995-08-11
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR (K951331)Boehringer Mannheim Corp.1995-08-11
MAGNESIUM REAGENT (K952426)Schiapparelli Biosystems, Inc.1995-08-07
ALANINE AMINOTRANSFERASE REAGENT SYSTEM (K952744)Medical Diagnostic Technologies, Inc.1995-08-07
LACTATE DEHYDROGENASE REAGENT SYSTEM (K952747)Medical Diagnostic Technologies, Inc.1995-08-07
AI-PHOTODIAGNOSTIC (K940004)Pharmarceutical Discovery Corp.1995-08-04
IL TEST CK-MB (K952646)Instrumentation Laboratory CO1995-08-04
MAGNETIC HDL CHOLESTEROL TEST (K944975)Reference Diagnostics, Inc.1995-08-02
5STRATEC SL 300 LIA-MAT (K950029)Nichols Institute Diagnostics1995-08-02
HICHEM AST REAGENT KIT (K951751)Hichem Diagnostics1995-08-02
BIO-RAD URINARY 5-HIAA BY HPLC (K952817)Bio-Rad1995-08-01
AMERLITE TBG ASSAY (K952284)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-26
ROBOCAP (K952025)Pharmacia, Inc.1995-07-26
IL TEST LIPASE (K952647)Instrumentation Laboratory CO1995-07-20
LIPASE FLEX REAGENT CARTRIDGE (K952816)Dupont Medical Products1995-07-20
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY (K952127)Boehringer Mannheim Corp.1995-07-20
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) (K944788)Scantibodies Laboratory, Inc.1995-07-19
HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY (K950354)Ml Strategies, Inc.1995-07-19
KENLOR LIQUID TOTAL URINE CONTROL (K952840)Kenlor Industries, Inc.1995-07-19
SELECTA 20/60 CHEMISTRY ANALYZER (K942922)Select Medical Systems, Inc.1995-07-19
ACTIVE FREE TESTOSTERONE RIA (K952281)Diagnostic Systems Laboratories, Inc.1995-07-17
AMERLITE HCG-60 ASSAY (K952283)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-17
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT (K952250)Dade Intl., Inc.1995-07-17
ACTIVE INTACT PTH ELISA (K952199)Diagnostic Systems Laboratories, Inc.1995-07-17
AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) (K952211)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-14
SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE (K926253)Sudormed, Inc.1995-07-14
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION (K935588)Sudormed, Inc.1995-07-14
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION (K935564)Sudormed, Inc.1995-07-14
PRO-VENT, LINE DRAW, PULSATOR (K952516)Smiths Industries Medical Systems, Inc.1995-07-14
GLUCOMETER ELITE M BLOOD GLUCOSE METER (K951537)Bayer Corp.1995-07-14
DADE STRATUS TROPONIN-I CONTROL (K951888)Dade Intl., Inc.1995-07-13
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS (K951890)Dade Intl., Inc.1995-07-13
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI (K942647)Scantibodies Laboratory, Inc.1995-07-12
CEDIA VITAMIN B12 (NO BOIL) ASSAY (K951134)Microgenics Corp.1995-07-11
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT (K951538)Syntron Bioresearch, Inc.1995-07-11
STAT PROFILE ULTRA BLOOD GAS CONTROLS (K952477)Nova Biomedical Corp.1995-07-06
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT (K952425)Olympus America, Inc.1995-07-05
AMERLITE FSH ASSAY (K952285)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-03
INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (K952505)Nichols Institute1995-07-03
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K950816)Lifescan, Inc.1995-07-03
LOK-ON NEEDLE DISPOSAL SYSTEM (K951886)Becton Dickinson Vacutainer Systems1995-06-30
HYDRAGEL PROTEIN(E) KIT (K951536)Sebia1995-06-30
AXSYM ULTRASENSITIVE HTSH II (K952148)Abbott Laboratories1995-06-29
CEDIA FOLATE (NO BOIL) ASSAY (K951155)Microgenics Corp.1995-06-29
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 (K950588)Biomerica, Inc.1995-06-29
SYNCHRON ENZYME VALIDATOR SET (K951964)Beckman Instruments, Inc.1995-06-29
IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (K946247)Nichols Institute1995-06-23
CONTRAST & RAPID HCG URINE/SERUM TST (K952319)Medix Biotech, Inc.1995-06-20
SYNERMED ISE REAGENTS (K952179)Synermed, Inc.1995-06-20
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT (K951332)Dade Intl., Inc.1995-06-19
T-UPTAKE CALIBRATORS (K951585)Diagnostic Reagents, Inc.1995-06-15
PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM (K952279)Medisense, Inc.1995-06-14
TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (K950234)Emd Chemicals, Inc.1995-06-14
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 (K951189)Beckman Instruments, Inc.1995-06-13
CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY (K951796)Ciba Corning Diagnostics Corp.1995-06-13
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (K952075)Bayer Corp.1995-06-13
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (K945800)Diagnostic Chemicals , Ltd.1995-06-09
ABBOTT PROJECT I, SPECTRUM (K945566)Abbott Laboratories1995-06-09
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 (K944999)More Diagnostics1995-06-06
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT (K952466)Olympus America, Inc.1995-06-05
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM (K950727)Lifescan, Inc.1995-06-01
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM (K950802)International Enzymes, Inc.1995-06-01
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION (K951058)Heraeus Kulzer, Inc.1995-06-01
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE (K944083)Sherwood Medical Co.1995-05-26
CR PERFECT (K950142)Chimera Research & Chemical, Inc.1995-05-25
MINI S.F.T. (URINE PRESERVATIVE) (K943466)Cambridge Diagnostic Products, Inc.1995-05-24
PROSTAT CONTROL (K943394)Quantimetrix Corp.1995-05-23
IMX ESTRADIOL (K951629)Abbott Laboratories1995-05-17
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 (K945651)Bio-Rad1995-05-16
ORTHO ALT MICROWELL TEST SYSTEM (K941192)Ortho Diagnostic Systems, Inc.1995-05-16
ABBOTT AXSYM II SYSTEM (K950915)Abbott Laboratories1995-05-16
COAT-A-COUNT LH IRMA (K951748)Diagnostic Products Corp.1995-05-15
HICHEM ALT REAGENT KIT (K951818)Hi Chem, Inc.1995-05-15
T-UPTAKE EIA TEST (K951586)Diagnostic Reagents, Inc.1995-05-15
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (K950524)Nichols Institute1995-05-15
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (K950128)Emd Chemicals, Inc.1995-05-15
ACE AMYLASE REAGENT (K951548)Schiapparelli Biosystems, Inc.1995-05-15
BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 (K951749)Biocell Laboratories, Inc.1995-05-15
NEONATAL BLOOD COLLECTION AND SCREENING FORM (K944618)General Business Forms, Inc.1995-05-10
ACTIVE IGF-I ELISA (K951752)Diagnostic Systems Laboratories, Inc.1995-05-10
DSL ACTIVE IFGBP-3 ELISA (K951707)Diagnostic Systems Laboratories, Inc.1995-05-10
AURAFLEX PROGESTERONE 150TEST PACK (K951630)Organon Teknika Corp.1995-05-08
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (K946354)Data Medical Associates, Inc.1995-05-08
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) (K950958)Beckman Instruments, Inc.1995-05-08
GLUCOSE (HK) REAGENT (PROCEDURE NO.16) (K945908)Sigma Diagnostics, Inc.1995-05-08
← Previous Next →

Track Clinical Chemistry automatically

Every clearance here is in the API, with alerts when new ones post.