Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
KM-KAL 6 (K823022)Kmn Products, Inc.1982-11-16
KM-KAL L6 (K823023)Kmn Products, Inc.1982-11-16
KM - KAL 1 (K823024)Kmn Products, Inc.1982-11-16
HYPOCOUNT A (K822976)Pharmaquest Corp.1982-11-16
KM - KAL 2 (K823025)Kmn Products, Inc.1982-11-16
KM-KAL 4 (K823020)Kmn Products, Inc.1982-11-16
KM - KAL 5 (K823021)Kmn Products, Inc.1982-11-16
QAP MICROCOMPUTER SYSTEM (K823110)American Dade1982-11-16
KM-KAL 3 (K823019)Kmn Products, Inc.1982-11-16
RERMCO TEST CHLORIDE REAGENT (K823106)Fermco Biochemics, Inc.1982-11-16
NML-TETRA-TUBE RIA (K823053)Nuclear Medical Laboratories, Inc.1982-11-10
ID-ZONE LD ISOENZYME CONTROL (K822984)Beckman Instruments, Inc.1982-11-10
GENERIC PREGNANCY TEST (K823109)Diagnostic Specialties1982-11-10
SYVA ADVANCE THYROXINE ASSAY (K823034)Syva Co.1982-11-08
KM-KAL L4 (K823045)Kmn Products, Inc.1982-11-05
DIGITAL DILUTER/DISPENSERS (K822688)Hamilton Co.1982-11-05
LANCER MSH GLUCOSE DIAG. KIT (K822958)Sherwood Medical Co.1982-11-05
PHADEBASE HUMYLASE CONTROL (K822938)Pharmacia, Inc.1982-11-05
COAT-A-COUNT FREE THYROXINE KIT/COMPONEN (K822882)Diagnostic Products Corp.1982-11-05
KM-KAL L2 (K823043)Kmn Products, Inc.1982-11-05
GLUCOSCAN METER MODEL II (K822699)Lifescan, Inc.1982-11-05
KM-KAL L5 (K823046)Kmn Products, Inc.1982-11-05
EMIT CLINICAL PROCESSOR #CP-5000 (K822932)Syva Co.1982-11-05
GLUCOSE/UREA NITROGEN STANDARD (K822937)Emd Chemicals, Inc.1982-11-05
KM-KAL L1 (K823042)Kmn Products, Inc.1982-11-05
BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT (K823004)Bioclinical Group1982-11-05
HOME BLOOD GLUCOSE MONITOR (K822486)Pharmaquest Corp.1982-11-05
SOLID PHASE SIMUL TRAC VITAMIN B12 (K822728)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-11-05
CORTISOL RIA KIT (K822892)Antibodies, Inc.1982-11-01
TITAN GEL CPK ISOENZYME SYSTEM (K822124)Helena Laboratories1982-11-01
THYROID STIMULATING HORMONE (K822935)Pcl-Ria, Inc.1982-11-01
TPK 1980/1 (K822449)Plantex USA, Inc.1982-10-27
TRIGLYCERIDE CALIBRATOR (K822852)Harleco Diagnostics1982-10-27
MICROFLUOR READER (K822772)Dynatech Corp.1982-10-27
PICOLITE (K822800)United Technologies Packard1982-10-27
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX (K822850)American Dade1982-10-27
SOPHEIA CORTISOL EIA KIT (K822845)Diagnostic Products Corp.1982-10-27
URIC ACID 75CDO (K822884)Technicon Instruments Corp.1982-10-27
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS (K822860)Ventrex Laboratories, Inc.1982-10-27
RADIOIMMUNOASSAY, HUMAN CHORRIONIC (K822840)Bioclinical Group1982-10-27
HISH EIA DIAGNOSTIC KIT (K822827)Abbott Laboratories1982-10-27
FOLATE/B12 DUO-BEAD RADIOASSAY (K822241)Abbott Laboratories1982-10-26
MICROMEDIC ESTRIOL RIA KIT (K822578)Micromedic Systems1982-10-26
MINISAMPLER TM (K822508)Bms, Inc.1982-10-22
NEW ENZYMATIC SINGLE REAGENT FREE CHOL. (K822417)Sclavo, Inc.1982-10-21
ABBOTT LABORATORIES PROLACTIN EIA (K822759)Abbott Laboratories1982-10-21
AMNISTAT-FLM (K822150)Hana Biologics, Inc.1982-10-21
BECKMAN ASTRA (K822039)Beckman Instruments, Inc.1982-10-21
SERAGAN ACTH125 I-RIA KIT (K822115)Seragen Diagnostics, Inc.1982-10-18
AHBD (K822739)Gilford Diagnostics1982-10-18
TAMDEM-R THYROID STIMULATING HORMONE KIT (K822705)Hybritech, Inc.1982-10-13
ENDAB THYROID UPTAKE (K822684)Immunotech Corp.1982-10-08
ADVANCE TM T-3 UPTAKE ASSAY (K822592)Syva Co.1982-10-08
MODEL 340 SPECTROPHOTOMETER (K822720)Abbott Diagnostics1982-10-08
COUNT-10 TROL (K822540)Texas Immunology, Inc.1982-10-08
FLUOROSTAT FLUOROMETER (K822701)Miles Laboratories, Inc.1982-10-08
UNIMETER 330K (K822441)Boehringer Mannheim Corp.1982-10-08
GLUCOSCAN TEST STRIPS (K822697)Lifescan, Inc.1982-09-30
ACA URINARY PROTEIN ANALYTICAL TEST PACK (K822231)E.I. Dupont DE Nemours & Co., Inc.1982-09-30
QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM (K822646)Beckman Instruments, Inc.1982-09-30
DSL 1400 (K822314)Diagnostic Systems Laboratories, Inc.1982-09-30
FERMCOTEST CO2 REAGNET (K822117)Fermco Biochemics, Inc.1982-09-30
LEECO T3% DIAGNOSTIC KIT (K822575)Leeco Diagnostics, Inc.1982-09-30
T3 UPTAKE KITS (K822612)Pcl-Ria, Inc.1982-09-30
PLATELET CENTRIFUGE (K822715)Biodynamics Corp.1982-09-30
GLUCOSCAN CONTROLS (K822698)Lifescan, Inc.1982-09-30
FERMCOTEST CREATININE TEST REAGENT (K822118)Fermco Biochemics, Inc.1982-09-30
COVALENT COAT RIA KIT (K822509)Immuchem Corp.1982-09-28
MODEL UCG ASSAY (K822520)Monoclonal Antibodies, Inc.1982-09-28
SERA CHEM SMAC CALIBRATORS (K822496)Fisher Scientific Co., LLC1982-09-21
CELLULOSE ACETATE MEMBRANE STRIPS (K822285)Sartorius Filters, Inc.1982-09-21
OPTIMIZED UV-GPT REAGENT SET (K822494)Biorent Diagnostic, Inc.1982-09-21
OPTIMIZED UV-GOT REAGENT SET (K822493)Biorent Diagnostic, Inc.1982-09-21
OPTIMIZED UV-LDH REAGENT SET (K822492)Biorent Diagnostic, Inc.1982-09-17
CALCIUM STANDARD, ITEM #65075 (K822473)Emd Chemicals, Inc.1982-09-17
CREATININE STANDARD #65072 (K822477)Emd Chemicals, Inc.1982-09-17
CHOLESTEROL STANDARD #65077 (K822474)Emd Chemicals, Inc.1982-09-14
B-HCG RADIOIMMUNOASSAY KIT (K822515)Bioclinical Group1982-09-14
PHOSPHOROUS STANDARD #65073 (K822476)Emd Chemicals, Inc.1982-09-14
PSI CALCIUM REAGENT (K822469)Pointe Scientific, Inc.,1982-09-14
PSI ALBUMIN REAGENT (K822471)Pointe Scientific, Inc.,1982-09-14
PSI INORGANIC PHOSPHORUS (K822470)Pointe Scientific, Inc.,1982-09-14
ULTRACHEM ENZYMATIC CHOL. OXIDASE (K822418)Emd Chemicals, Inc.1982-09-14
TOTAL PROTEIN STANDARD, #65074 (K822475)Emd Chemicals, Inc.1982-09-14
ALBUMIN STANDARD, #65070 (K822478)Emd Chemicals, Inc.1982-09-14
PSI TOTAL PROTEIN REAGENT (K822468)Pointe Scientific, Inc.,1982-09-14
ENZYMUNE SYSTEM I (K822465)Icl Scientific1982-09-14
BILIRUBIN CALIBRATOR #65071 (K822479)Emd Chemicals, Inc.1982-09-14
LH (125I) RADIOIMMUNOASSAY (K822288)Corning Medical & Scientific1982-09-13
LEECO T4 QUANT DIAGNOSTICS TEST KIT (K822399)Leeco Diagnostics, Inc.1982-09-13
BASIC CENTRIFUGE (K822422)Biodynamics Corp.1982-09-02
DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (K822298)Nuclear Medical Laboratories, Inc.1982-09-02
ULTRACHEM BUN-UV, 65080 & 65081 (K822323)Harleco Diagnostics1982-09-02
B-HCG (K822343)Diagnostic Products Corp.1982-09-02
BILIRUBIN CALIBRATORS (K822334)Gilford Diagnostics1982-09-02
HCG BETA RIA KIT (K822152)Clinetics Corp.1982-09-02
QUANTIMUNE HTSH IRMA (K822291)Bio-Rad1982-08-27
RAICHEM LDH-L REAGENT (K822312)Reagents Applications, Inc.1982-08-27
CAVRO IQ-190 SAMPLE PROCESSOR (K822208)Cavro Scientific Instruments, Inc.1982-08-27
SYVA LAB PROCESSOR 6000 (K822381)Syva Co.1982-08-27
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