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
QUICK CHECK 3 FILM (K903191)Quantai Biotronics, Inc.1990-10-15
SYNCHRON CX4-CE (K904220)Beckman1990-10-15
DUPONT DRUG CALIBRATOR-A (K904306)E.I. Dupont DE Nemours & Co., Inc.1990-10-15
SYNERMED ALBUMIN REAGENT KIT (K903543)Synermed, Inc.1990-10-12
DIAZO COLORIMENTRY DIRECT BILIRUBIN (K904381)Amresco, Inc.1990-10-12
SECONDARY CALIBRATORS (K904335)Bionostics, Inc.1990-10-12
IL T UPTAKE ASSAY SYSTEM (K903396)Instrumentation Laboratory CO1990-10-12
ROCHE COBAS READY GGT REAGENT (K903304)Roche Diagnostic Systems, Inc.1990-10-12
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) (K904293)Hichem Diagnostics1990-10-12
ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM (K903391)Nichols Institute1990-10-12
TDX FREE T3 CALCULATION (K903433)Abbott Laboratories1990-10-12
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (K904049)Roche Diagnostic Systems, Inc.1990-10-12
MILENIA (TM) LH (K902786)Diagnostic Products Corp.1990-10-12
SYNERMED LDH REAGENT KIT (K903773)Synermed, Inc.1990-10-12
LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION (K904458)London Diagnostics, Inc.1990-10-12
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 (K903933)Baxter Healthcare Corp1990-10-04
GEN-PROBE PAL LUMINOMETER (K903911)Gen-Probe, Inc.1990-10-04
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE (K903409)Em Diagnostic Systems, Inc.1990-10-04
SYNERMED CALCIUM REAGENT KIT (K903233)Synermed, Inc.1990-10-04
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) (K902575)Diagnostic Products Corp.1990-10-04
SUDORMED SWEAT PATCH SPECIMEN CONTAINER (K902442)Sudormed, Inc.1990-10-04
CREATINE PHOSPHOKINASE (K903775)Amresco, Inc.1990-10-04
CIBA CORNING ACS HCG IMMUNOASSAY (K904123)Ciba Corning Diagnostics Corp.1990-10-03
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK (K903914)Baxter Healthcare Corp1990-10-03
TRIGLYCERIDES REAGENT GPO 5 X CONC. (K903897)Trace Scientific , Ltd.1990-10-01
SYNERMED CHOLESTEROL REAGENT KIT (K903015)Synermed, Inc.1990-10-01
N-A-G TEST KIT (K893582)Ppr Diagnostics , Ltd.1990-10-01
COULOCHEM II (K903231)Esa, Inc.1990-09-27
SYVA(R) ETS(R) PLUS SYSTEM (K903357)Syva Co.1990-09-27
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN (K903071)Eastman Kodak Company1990-09-27
HI CHEM PROTEIN/LIPIDS LINEARITY (K903888)Hichem Diagnostics1990-09-27
TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (K903305)Technicon Instruments Corp.1990-09-27
CEDIA TOTAL T3 ASSAY (K904098)Microgenics Corp.1990-09-27
IRON 5 X CONC REAGENT (K904116)Trace Scientific , Ltd.1990-09-27
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II (K903913)Baxter Healthcare Corp1990-09-27
GEN-PROBE LUMINOMETER-LEADER 50 (K903934)Gen-Probe, Inc.1990-09-27
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER (K904188)Ciba Corning Diagnostics Corp.1990-09-27
SYNERMED URIC ACID REAGENT KIT (K903727)Synermed, Inc.1990-09-27
REFLOTRON CREATINE KINASE TEST TABS (K904102)Boehringer Mannheim Corp.1990-09-27
ROCHE COBAS READY HDL CHOLESTEROL REAGENT (K902935)Roche Diagnostic Systems, Inc.1990-09-27
SYNERMED ALKALINE PHOSPHATASE REAGENT KIT (K904030)Synermed, Inc.1990-09-27
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2) (K903144)Eastman Kodak Company1990-09-25
LIQUID STABLE CHOLESTEROL REAGENT KIT (K902678)Trace Scientific , Ltd.1990-09-25
ABBOTT TESTPACK PLUS TM HCG-COMBO (K903219)Abbott Laboratories1990-09-25
AST REAGENT (K903829)Amresco, Inc.1990-09-25
LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY (K903130)London Diagnostics, Inc.1990-09-25
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III (K903566)Baxter Healthcare Corp1990-09-24
MILENIA PAP IRMA CATALOG #: MKPA1, X (K902937)Diagnostic Products Corp.1990-09-21
VEN-O-VAC BLOOD COLLECTION VACUUM TUBES (K900856)Artefactos DE Vidrio S.A. DE C.V.1990-09-21
SYNERMED DIRECT BILIRUBIN REAGENT KIT (K903728)Synermed, Inc.1990-09-21
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT (K903123)Reagents Applications, Inc.1990-09-14
SYNERMED GLUCOSE REAGENT KIT (K903063)Synermed, Inc.1990-09-13
CALCIUM ARSENAZO III REAGENT (K903896)Trace Scientific , Ltd.1990-09-13
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 (K904007)Amresco, Inc.1990-09-13
ALANINE AMINOTRANSFERASE TEST (K903198)Em Diagnostic Systems, Inc.1990-09-12
OLYMPUS INORGANIC PHOSPHORUS (K903696)Em Diagnostic Systems, Inc.1990-09-12
MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE (K903647)Millipore Corp.1990-09-11
ABBOTT VISION LYTE (TM) SODIUM (K903188)Abbott Laboratories1990-09-10
TDX FREE T4 CALCULATION (K903383)Abbott Laboratories1990-09-10
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) (K903616)Diagnostic Systems Laboratories, Inc.1990-09-10
IMX FREE T4 CALCULATION (K903384)Abbott Laboratories1990-09-10
ACID PHOSPHOTASE REAGENT TEST AND KIT (K902543)Crestat Diagnostics, Inc.1990-09-07
IMX FREE T3 CALCULATION (K903432)Abbott Laboratories1990-09-07
NOVAPATH TSH ENZYME IMMUNOASSAY (K903311)Bio-Rad1990-09-07
SYNERMED TOTAL PROTEIN REAGENT KIT (K903511)Synermed, Inc.1990-09-07
ABBOTT IMX FREE T4 (K902834)Abbott Laboratories1990-09-07
UREA NITROGEN TEST (K903334)Em Diagnostic Systems, Inc.1990-09-07
ROCHE COBAS READY CREATININE REAGENT (K902561)Roche Diagnostic Systems, Inc.1990-09-07
LABELLING CHANGES TO IMPRES-MB-X (K903508)Intl. Immunoassay Laboratories, Inc.1990-09-07
AIA-PACK IRI (K903628)Tosoh Corp.1990-09-07
REFLOTRON CREATININE TEST TABS (K903573)Boehringer Mannheim Corp.1990-09-07
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR (K903310)Medical Analysis Systems, Inc.1990-09-07
KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL (K903338)Kenlor Industries, Inc.1990-09-07
AFFINITY HLH TEST SYSTEM (K903407)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-09-07
ROCHE COBAS READY AMYLASE REAGENT (K903309)Roche Diagnostic Systems, Inc.1990-09-07
STAT TEST HDL/CHOLESTEROL TEST KIT (K903094)Diagnostic Resources, Inc.1990-08-29
IMMUNOCORP LH IRMA COATED TUBE (K903052)Immunocorp Sciences, Inc.1990-08-29
TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (K903306)Technicon Instruments Corp.1990-08-29
INTERJECTOR BLOOD COLLECTION DEVICE (K901756)Bowman/Vector, Inc.1990-08-29
YSI MODEL 1500 SPORT L-LACTATE ANALYZER (K901131)Yellow Springs Instrument Co., Inc.1990-08-27
IMX B12 (K903218)Abbott Laboratories1990-08-23
IL THYROXINE (T4) ASSAY SYSTEM (K903095)Instrumentation Laboratory CO1990-08-23
LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 (K903430)Bio-Rad1990-08-23
STANBIO CSF/URINE TOTAL PROTEIN TEST SET (K902204)Stanbio Laboratory1990-08-22
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (K903359)Immunotech Corp.1990-08-22
MAGNESIUM (K903341)Catachem, Inc.1990-08-22
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL (K902909)Creative Laboratory Products, Inc.1990-08-22
COBAS READY CALCIUM REAGENT (K896224)Roche Diagnostic Systems, Inc.1990-08-17
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 (K903332)Em Diagnostic Systems, Inc.1990-08-17
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY (K903190)Medical Analysis Systems, Inc.1990-08-17
ASPARTATE AMINOTRANSFERASE TEST (K903197)Em Diagnostic Systems, Inc.1990-08-17
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT (K903225)Medical Analysis Systems, Inc.1990-08-17
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (K903335)Em Diagnostic Systems, Inc.1990-08-17
SYNERMED CREATININE REAGENT KIT (K903296)Synermed, Inc.1990-08-17
CREATINE KINASE TEST (CK) ITEM NUMBER 65411 (K903333)Em Diagnostic Systems, Inc.1990-08-17
EURAMARK 610 PHOTOMETER (K903164)Euro-American Marketing Group, Inc.1990-08-09
AFFINITY HCG TEST SYSTEM (K902720)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-08-09
SYNERMED CHLORIDE REAGENT KIT (K903103)Synermed, Inc.1990-08-09
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF (K902569)Boehringer Mannheim Corp.1990-08-09
VACUTAINER PLUS WITH HEMOGARD CLOSURE (K901449)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-08-09
← Previous Next →

Track Clinical Chemistry automatically

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