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
IRON/TOTAL IRON BINDING CAPACITY (K901561)Tech-Co, Inc.1990-05-17
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI (K901017)E.I. Dupont DE Nemours & Co., Inc.1990-05-15
ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER (K900887)Abbott Laboratories1990-05-15
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB (K901450)Intl. Immunoassay Laboratories, Inc.1990-05-15
ENZYMUN TEST(R) FT4 (FREE THYROXINE) (K900883)Boehringer Mannheim Corp.1990-05-15
WAKO(TM) AUTOKIT URIC ACID (K901544)Wako Chemicals USA, Inc.1990-05-14
CHEM I CLINICAL ANALYZER URINE MAGNESIUM (K901124)Technicon Instruments Corp.1990-05-14
MPR-4A - MICRO-PLATE READER (K901965)Tosoh Corp.1990-05-10
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN (K901123)Technicon Instruments Corp.1990-05-10
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 (K901345)Medix Biotech, Inc.1990-05-10
OLYMPUS(TM) TOTAL BILIRUBIN (K897174)Em Diagnostic Systems, Inc.1990-05-10
BIOSIGN HCG-ONE STEP PREGNANCY TEST (K901011)Princeton Biomedix1990-05-04
CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) (K901229)Technicon Instruments Corp.1990-05-04
MICROTEK MEDICAL'S BLOOD COLLECTION KIT (K900726)Microbio-Medics, Inc.1990-05-04
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) (K901807)Em Diagnostic Systems, Inc.1990-05-02
ENZYMUN TEST(R) CORTISOL (K900485)Boehringer Mannheim Corp.1990-05-02
AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K901674)Tosoh Corp.1990-05-02
COLORIMETRIC CHLORIDE PRODUCT #4314125 (K900827)American Research Products Co.1990-05-02
LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC (K901484)London Diagnostics, Inc.1990-05-01
LIG/TDM A, B, C (K901212)Ciba Corning Diagnostics Corp.1990-05-01
DILECTRON URINARY CONDUCTIVITY PROBE (K891681)Gyrus Medical , Ltd.1990-05-01
TECHNICON TESTPOINT(TM) LIGAND CONTROL (K900717)Technicon Instruments Corp.1990-04-26
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE (K901542)Source Scientific Systems, Inc.1990-04-26
CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY (K901298)Olympus Corp.1990-04-25
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 (K901702)American Research Products Co.1990-04-25
BLOOD GAS CALIBRATION STANDARD (K900819)Cryogenic Rare Gas Laboratories, Inc.1990-04-25
COULTER TOTAL BILIRUBIN REAGENT (K901266)Coulter Corp.1990-04-25
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC (K901693)Technicon Instruments Corp.1990-04-25
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 (K901578)Diagnostic Products Corp.1990-04-19
MULTICONSTITUENT SERUM RANGE LINEARITY #88234 (K901115)Hichem Diagnostics1990-04-19
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) (K901226)Technicon Instruments Corp.1990-04-19
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 (K900667)American Research Products Co.1990-04-19
AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 (K900666)American Research Products Co.1990-04-19
IMX HCG (LIST #03A63) (K900327)Abbott Laboratories1990-04-18
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (K901083)Em Diagnostic Systems, Inc.1990-04-16
CHEM-CHEX (K900993)Streck Laboratories, Inc.1990-04-16
KEMBLE LIQUID HANDLING SYSTEM DISPENSER (K896684)Schiff & Co.1990-04-16
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) (K900571)American Research Products Co.1990-04-16
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER (K901003)Boehringer Mannheim Corp.1990-04-16
COULTER GAMMA-GT (GGT) REAGENT (K901264)Coulter Corp.1990-04-16
ES 300 IMMUNOASSAY SYSTEM (K901346)Boehringer Mannheim Corp.1990-04-16
CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) (K901137)Technicon Instruments Corp.1990-04-12
ENZYMUN TEST(R) TSH-S (K900277)Boehringer Mannheim Corp.1990-04-11
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 (K900977)American Research Products Co.1990-04-11
DU PONT VISTA(R) IMMUNOASSAY SYSTEM (K900245)E.I. Dupont DE Nemours & Co., Inc.1990-04-11
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (K900394)American Research Products Co.1990-04-11
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX (K901141)Baxter Healthcare Corp1990-04-09
AUTOMATED EIA MICROPLATE READER MODELS EL340/340I (K901059)Bio-Tek Instruments, Inc.1990-04-09
AUTOMATED EIA MICROPLATE READER MODELS EL312/312I (K901027)Bio-Tek Instruments, Inc.1990-04-09
PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. (K900828)The Perkin-Elmer Corp.1990-04-09
COULTER AMYLASE REAGENT (K900230)Coulter Corp.1990-04-03
SIGMA PROCEDURE NO. 735 (K897147)Sigma Diagnostics, Inc.1990-04-03
EXEC-WASH SOLID PHASE WASHING SYSTEM (K896631)Source Scientific Systems, Inc.1990-04-03
TECHNICON AXON SYSTEM REAGENT METHODS (K900905)Technicon Instruments Corp.1990-04-03
ENZYMUN TEST(R) INSULIN (K901135)Boehringer Mannheim Corp.1990-04-03
NOVAPATH MICROPLATE READER (K900776)Bio-Rad1990-04-03
CEDIA (TM) CORTISOL ASSAY (K901296)Microgenics Corp.1990-04-03
ENZYMUN TEST(R) LH (K900779)Boehringer Mannheim Corp.1990-04-03
COULTER CALCIUM REAGENT (K900231)Coulter Corp.1990-04-03
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR (K900010)Kallestad Diag, A Div. of Erbamont, Inc.1990-04-03
ROCHE REAGENT FOR LDH (K900121)Roche Diagnostic Systems, Inc.1990-03-30
DELFIA TBG KIT (K900240)Pharmacia, Inc.1990-03-30
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS (K897183)Beckman Instruments, Inc.1990-03-30
ENZYMUN TEST(R) PROLACTIN (K900695)Boehringer Mannheim Corp.1990-03-30
GLUCOMETER GX BLOOD GLUCOSE METER (K897015)Heraeus Kulzer, Inc.1990-03-29
FREE T4 IMMUNOASSAY KIT (K900060)Advanced Magnetics, Inc.1990-03-29
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE (K901122)Technicon Instruments Corp.1990-03-29
MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD (K901113)Verichem Laboratories, Inc.1990-03-29
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR (K897072)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-29
COULTER CHOLESTEROL REAGENT (K897162)Coulter Electronics, Inc.1990-03-29
COULTER MAGNESIUM REAGENT (K901265)Coulter Corp.1990-03-29
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 (K900850)Em Diagnostic Systems, Inc.1990-03-29
ELITECH GAMMA GT TEST KIT (K901090)Elite Technology, Inc.1990-03-29
HCG SOLID PHASE COMPONENT SYSTEM (K901045)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-03-29
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE (K897177)Nova Biomedical Corp.1990-03-27
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K900806)Baxter Healthcare Corp1990-03-23
PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT (K901104)Baxter Healthcare Corp1990-03-23
PARAMAX ALANINE AMINOTRANSFERASE REAGENT (K901105)Baxter Healthcare Corp1990-03-23
IRON LIQUID STABLE REAGENT (K900902)Medical Analysis Systems, Inc.1990-03-19
OPUS T4 TEST SYSTEM (K897193)Pb Diagnostic Systems, Inc.1990-03-19
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX (K897176)Em Diagnostic Systems, Inc.1990-03-19
LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES (K893740)Reference Diagnostics, Inc.1990-03-19
VENOJECT II BLOOD COLLECTION TUBES (K900309)Terumo Medical Corp.1990-03-15
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT (K897144)Medix Biotech, Inc.1990-03-15
ENZYMUN TEST(R) FSH (K900763)Boehringer Mannheim Corp.1990-03-15
OLYMPUS DIRECT BILIRUBIN (K897175)Em Diagnostic Systems, Inc.1990-03-15
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM (K900775)Bio-Rad1990-03-09
COULTER GLUCOSE REAGENT (K897160)Coulter Electronics, Inc.1990-03-09
TOSOH AIA-PACK T3 (K897001)Tosoh Corp.1990-03-09
AFFINITY(TM) HTSH(TM) (K897138)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-03-09
COULTER TRIGLYCERIDES GPO REAGENT (K897159)Coulter Electronics, Inc.1990-03-09
ROCHE STANDARDS FOR THE COBAS ISE MODULE (K897071)Roche Diagnostic Systems, Inc.1990-03-09
IMMUNOTECH HDL-CHOLESTEROL TEST (K900036)Immunotech Corp.1990-03-09
COULTER ALT (GPT) REAGENT (K897163)Coulter Electronics, Inc.1990-03-09
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL (K900120)Roche Diagnostic Systems, Inc.1990-03-09
COULTER LD (LDH-L) REAGENT (K897164)Coulter Electronics, Inc.1990-03-09
AIA-PACK T4 (K896982)Tosoh Corp.1990-03-09
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT (K896482)Pacific Biotech, Inc.1990-03-06
IMMUNOTECH CHOLESTEROL TEST (K897036)Immunotech Corp.1990-03-06
STAT FAX(TM)-2100 (K900224)Awareness Technology, Inc.1990-03-01
← Previous Next →

Track Clinical Chemistry automatically

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