Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
COUNTER, RADIOASSAY, AUTO., MICROMEDIC (K780383)Micromedic Systems1978-03-22
SPECTROPHOTOMETER, ABSORPTION, ATOMIC (K780390)Varian Assoc., Inc.1978-03-22
ANALYZER, 100, BICHROMATIC, ABBOTT (K780388)Syva Co.1978-03-22
T3 UPTAKE TEST (K780361)Monobind1978-03-22
REAGENTS, MANUEAL, ASSAY, THYROXINE (K780121)Syva Co.1978-03-17
ANALYZER, SELECTIVE, ELECTRONIC (K780083)Johns Scientific, Inc.1978-03-09
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. (K780141)Harleco1978-03-09
ULTRAZYME PLUS GT (K780099)Harleco1978-03-09
TRIGLYCERIDE INSTRUMENT APPLICATION (K780172)Harleco1978-03-09
ULTRAZYME PLUS CK-1 (K780100)Harleco1978-03-09
LDH ISOENZYME CONTROL SERUM (K780096)Worthington Biochemical Corp.1978-03-03
CHEMISTRY CONTROL & REFERENCE SERUMS (K780204)Hyland Therapeutic Div., Travenol Laboratories1978-03-03
AUTOZYME GLUCOSE OXIDASE (TRINDER) (K772308)J.T. Baker Chemical Co.1978-03-03
RIA FOR FOLATES & VIT. B12, COMBO KIT (K780148)Ria Products, Inc.1978-03-03
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY (K780219)Syva Co.1978-03-03
CSF TOTAL PROTEIN TEST SET #0340 (K780110)Stanbio Laboratory1978-03-03
ASPIRATOR, MANUEL (K780208)Dade, Baxter Travenol Diagnostics, Inc.1978-03-03
TRIA-PEG RIA DIAG. KIT (K780292)Nuclear Diagnostics, Inc.1978-03-02
FLAME PHOTOMETER STANDARD (K772153)Alko Scientific Co.1978-02-28
PREDICTOR (K780240)Organon, Inc.1978-02-27
SPECTROPHOTOMETER, MODEL 380 (K780156)Turner Assoc.1978-02-23
T3 STI KIT (K780146)Polysciences, Inc.1978-02-23
ISOENZYME SERUM CONTROL (K780147)Corning Medical & Scientific1978-02-23
LIQUID SCINTILLATION COUNTER (K780179)Roche Medical Electronics, Inc.1978-02-23
GLUCOSE REAGENT SET (K780072)Medical Analysis Systems, Inc.1978-02-14
GAMA-GPT REAGENT SET (K780071)Medical Analysis Systems, Inc.1978-02-14
BUN REAGNET SET (K780069)Medical Analysis Systems, Inc.1978-02-14
ULTRAZYME PLUS LDH (K780101)Harleco1978-02-14
CPK REAGENT SET (K780070)Medical Analysis Systems, Inc.1978-02-13
ULTRAZYME PLUS GOT (K780103)Harleco1978-02-13
ULTRAZYME PLUS HBD (K780104)Harleco1978-02-13
HBDH REAGENT SET (K780073)Medical Analysis Systems, Inc.1978-02-13
RABBIT ANTIBODY/THYROID STIMUL. HORMONE (K780059)Pcl-Ria, Inc.1978-02-13
THYROXINE STDS. IN HUMAN SERUM (K780050)Pcl-Ria, Inc.1978-02-13
ULTRAZYME PLUS GPT (K780102)Harleco1978-02-13
ULTRAZYME PLUS ALP (K780095)Harleco1978-02-13
IRON BINDING CAPACITY CHEMISTRY (K780094)Harleco1978-02-13
GLUCOSE REAGENT FOR GLUCOSE ANALYZER (K780093)Harleco1978-02-13
THYRO-INDICATOR T-3 125I (K780018)Clinical Immuno-Diagnostics1978-02-07
THYROID STIMULATING HORMONE (K780015)Pcl-Ria, Inc.1978-02-07
LACTATE DEHYDROGENASE COLORIMETRIC SUB. (K780080)Corning Medical & Scientific1978-02-07
ULTRACHEM ALBUMIN (K780092)Harleco1978-02-07
ALP REAGENT SET (K780068)Medical Analysis Systems, Inc.1978-02-07
HUMAN FOLLICLE STIMULATING HORMONE (K780016)Pcl-Ria, Inc.1978-02-03
HTSH RIA (K780122)Abbott Laboratories1978-02-03
ULTRACHEM E-GLU, MANUAL DETERM. (K780065)Harleco1978-02-01
LACTATE DEHYDROGENASE (K780041)Beckman Instruments, Inc.1978-02-01
HYDORRYBUTYRATE DEHYDROGENASE (K780042)Beckman Instruments, Inc.1978-02-01
ALANINE TRANSAMINASE (K780040)Beckman Instruments, Inc.1978-01-31
DATA ACQUISITION & COLLATING SYS. (K772344)Gilford Instrument Laboratories, Inc.1978-01-31
STAC SYSTEM - ADDITIONAL ANALYTES (K772352)Technicon Instruments Corp.1978-01-31
ASPARTATE TRANSAMINASE (K780039)Beckman Instruments, Inc.1978-01-31
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE (K780013)Macomb Chemical Co.1978-01-30
SPECTROPHOTOMETER, MODEL 5000 (K780112)The Perkin-Elmer Corp.1978-01-30
17-HYDROXY TEST (K772426)Hycel, Inc.1978-01-30
LASER IMMUNONEPHELOMETRIC ANALYZER (K772361)G.D. Searle and Co.1978-01-30
PRINTER (K772099)Miles Laboratories, Inc.1978-01-26
LDH ISOENZYME COLUMN REAGENT SET (K772356)Worthington Biochemical Corp.1978-01-24
FLUORESCENCE DETECTOR MODEL 420 (K780031)Waters Assoc., Inc.1978-01-20
INSULIN RIA MODULE (K771947)Inter Science Institute1978-01-20
GLUCAGON RIA MODULE (K771948)Inter Science Institute1978-01-20
GASTRIN RIA MODULE (K771953)Inter Science Institute1978-01-20
T4 RIA KIT (K772330)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-01-12
WISP MODEL 710 (K772311)Waters Assoc., Inc.1978-01-12
DENSITOMETER 18, COMPUTING, AUTO. (K772325)Gelman Instrument Co.1978-01-12
ANALYZER, CLINICAL, SYSTEM 3 (K772319)Gilford Instrument Laboratories, Inc.1978-01-12
TESTOSTERONE RIA KIT (125I) (K772191)Diagnostic Products Corp.1978-01-12
NEONATAL TSH RIA KIT (125I) (K772192)Diagnostic Products Corp.1978-01-12
URINARY 17-KETOSTERIOD/17 (K772337)Eppendorf-Brinkmann, Inc.1978-01-12
IMMO PHASE FT4 ASSAY (K772194)Corning Medical & Scientific1978-01-06
RSL INSULIN KIT (K772281)Radioassay Systems Laboratories, Inc.1978-01-06
ACA LIPASE VERIFIERS (K772285)E.I. Dupont DE Nemours & Co., Inc.1978-01-06
CLINICARD CK-II (K772258)Harleco1978-01-05
RIANEN ESTRIOL RIA KIT (K772323)New England Nuclear1978-01-05
RIA FOR SERUM THYROXINE (K771415)Clinical Immuno-Diagnostics1978-01-05
PREGNANCY TEST KIT, ANSWER (K772359)Diagnostic Testing, Inc.1978-01-05
AUTO. SAMPLING SYSTEM (K772364)Hewlett-Packard Co.1978-01-05
LDH ISOENZYME CONTROL (K771894)Bio-Reagents & Diagnostics, Inc.1977-12-22
ALKALINE PHOSPHATASE TEST SET (K772257)Stanbio Laboratory1977-12-22
SPINSEP-T3 (K771854)Nuclear Diagnostics, Inc.1977-12-22
EMIT CENTRIFICHEM THYROXINE ASSAY (K772170)Syva Co.1977-12-22
PCO 2 ELECTROLYTE (K772307)Fisher Scientific Co., LLC1977-12-22
UNCONJUGATED ESTRIOL RIA KIT (K772215)Amersham Corp.1977-12-22
COMPLEMENT C3 NEPHELOMETRIC ASSAY (K772249)Kallestad Laboratories, Inc.1977-12-22
TRI-TAB-RIA (K772177)Nuclear Medical Laboratories, Inc.1977-12-22
DUAL WAVELENGTH PHOTOMETER, 1177 (K771909)Abbott Laboratories1977-12-20
THYROID BINDING GLOBULIN (K772183)Corning Medical & Scientific1977-12-20
CYSTIC FIBROSIS TESTING INSTRUMENT (K772176)Laboratory Equipment Design Co.1977-12-20
PEDIATRIC THYROXINE TEST SYS. T4 (K771609)Corning Medical & Scientific1977-12-20
PH CALIBRATION BUFFERS (K772106)General Diagnostics1977-12-06
DYNAZYME TM II CARDIAK-MB (K772172)J.T. Baker Chemical Co.1977-12-06
AUTOMATIC ANALYZER (K771662)Lachat Chemicals, Inc.1977-12-06
PHOSPHATE (K771906)Simmler & Son, Inc.1977-12-06
GLYCEROL SUBSTRATE (K771905)Simmler & Son, Inc.1977-12-06
ULTRACHEM PHOSPHORUS, 64973 (K772156)Harleco1977-12-06
AMES T-3 UPTAKE STRIP TEST (K772088)Miles Laboratories, Inc.1977-12-06
LIPASE (K771903)Simmler & Son, Inc.1977-12-06
GLYCEROL KINASE (K771904)Simmler & Son, Inc.1977-12-06
IN VITRO HUMAN TSH RIA TEST (K772109)Clinical Assays, Inc.1977-12-06
ULTRACHEM TOTAL PROTEIN, #64974 (K772155)Harleco1977-12-06
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