Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
ENZYMUNE-TEST T4 (K820750)Icl Scientific1982-04-06
MR1 FOLLITROPIN RIA KIT (K820740)Microanalytic Research, Inc.1982-04-06
QUANTIMUNE ESTRIOL RIA (K820728)Bio-Rad1982-04-06
KODAK EKTACHEM CLINICAL CHEM. NH3 (K820723)Eastman Kodak Company1982-04-01
NOVA I FLUIDS PACK (K820701)Shaban Mfg. Co.1982-04-01
SYVA ADVANCE STANDARDIZATION KIT 01 (K820698)Syva Co.1982-04-01
MONOJECT CORVAC STAT VAC TUBE W/THROM (K820717)Sherwood Medical Co.1982-04-01
1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (K811927)Corning Medical & Scientific1982-04-01
DUPONT AUTOMATIC CLINICAL ANALYZER (K820687)E.I. Dupont DE Nemours & Co., Inc.1982-04-01
ROCHE B-HCG STANDARDS (K820614)Hoffmann-La Roche, Inc.1982-04-01
CORNING 480 FLAME PHOTOMETER (K820631)Corning Medical & Scientific1982-04-01
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE (K820722)Eastman Kodak Company1982-04-01
ROCHE B-HCG RIA (K820613)Hoffmann-La Roche, Inc.1982-04-01
LIQUISOL PROGESTERONE RADIOIMMUNO (K820686)Damon Corp.1982-04-01
BILIRUBIN(TOTAL) DETERMINATION CTMS (K820675)The Dow Chemical Co.1982-04-01
GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL (K820705)United Diagnostics, Inc.1982-04-01
COMPUTERIZED INTERPRETATION OF ARTERIAL (K820721)Philip R. Corsello, M.D.1982-04-01
RAICHEM TM CREATINE KINASE REAGENT (K820644)Reagents Applications, Inc.1982-04-01
DOW BILIRUBIN(DIRECT) DETERMINATION (K820714)The Dow Chemical Co.1982-04-01
EXTERNAL STANDARDS-SODIUMNPOTASSIUM (K820700)Shaban Mfg. Co.1982-04-01
158 BLOOD GAS ANALYZER (K820597)Corning Medical & Scientific1982-03-26
ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY (K820616)E. R. Squibb & Sons, Inc.1982-03-26
CENTRIA PROLACTIN TEST SET (K813572)Ventrex Laboratories, Inc.1982-03-26
FOLLICLE STIMULATING HORMONE KIT (K820358)Pcl-Ria, Inc.1982-03-26
CORNING 902 SODIUM POTASSIUM ANALYZER (K820629)Corning Medical & Scientific1982-03-25
LUTEINIZING HORMONE KIT (K820357)Pcl-Ria, Inc.1982-03-25
FETAL-TEK CONTROL MATURE (K820319)Helena Laboratories1982-03-25
COLORIMETRIC URIC ACID REAGENT SET (K820632)Biorent Diagnostic, Inc.1982-03-25
PHADEZYM ANALYZER (K813563)Pharmacia, Inc.1982-03-22
COAT-A-COUNT PROGESTERONE KIA KIT (K820534)Diagnostic Products Corp.1982-03-16
MICROMEDIC SYSTEMS ISOFLEX (K820376)Micromedic Systems1982-03-16
RAICHEM GPT (ALT) REAGENT (K820525)Reagents Applications, Inc.1982-03-15
CHORIO-QUANT (K820523)Nuclear Medical Laboratories, Inc.1982-03-15
CENTRIFREE MICROPARTITION SYSTEM (K820455)Amicon, Inc.1982-03-15
TOTAL LIPID REAGENT SET (K820500)Anco Medical Reagents & Assoc.1982-03-11
SGPT REAGENT SET (K820491)Anco Medical Reagents & Assoc.1982-03-11
IMMOPHASE B HCG RADIOIMMUNOASSAY (K820321)Corning Medical & Scientific1982-03-11
ABBOTT LABORATORIES B-HCG EIA (K820271)Abbott Laboratories1982-03-11
MIN-MOLECULE PTH BY RADIOIMMUNOASSAY (K820228)Immuno Nuclear Corp.1982-03-11
4150 ALPHA AMINO ACID ANALYZER (K820415)Lkb Instruments, Inc.1982-03-11
LIQUIZYME NA+/K+ REAGENT SET (K820395)American Research Products Co.1982-03-11
IL 8060 DATA MANAGEMENT SYSTEM (K820427)Instrumentation Laboratory CO1982-03-11
ENZYMATIC CHOLESTEROL REAGENT SYSTEM (K820473)American Monitor Corp.1982-03-11
CHEMSTRIP UG (K820465)Biodynamics Corp.1982-03-11
K.D. COLORIMETRIC BLOOD UREA N2 TEST (K820418)King Diagnostics, Inc.1982-03-11
SGOT REAGENT SET (K820466)Anco Medical Reagents & Assoc.1982-03-11
LIQUIZYME CHLORIDE REAGENT (K820411)American Research Products Co.1982-03-08
LD-L TRIS SYSTEM PACK TEST (K820378)Boehringer Mannheim Corp.1982-03-08
LIQUIZYME CO2REAGENT SET (K820388)American Research Products Co.1982-03-08
TECHNICON RA-1000 SYSTEM ADD. ANALYT (K820394)Technicon Instruments Corp.1982-03-08
NO-BOIL VITABIN B12 5760 FOLATE 125I (K813183)Corning Medical & Scientific1982-03-05
T3 UPTAKE-SQUIBB DIAGNOSTIC KIT (K820340)E. R. Squibb & Sons, Inc.1982-03-04
ESTRADIOL KIT BY RIA (K820329)Immuchem Corp.1982-03-04
AALTO LDH ISOENZYME CONTROL SERUM (K820360)Aalto Scientific, Ltd.1982-03-04
CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT (K820341)E. R. Squibb & Sons, Inc.1982-03-04
MODEL 3030 ATOMIC ABSORPTION SPECTRO- (K820320)The Perkin-Elmer Corp.1982-03-01
AIRMED SMOKE EVACUATION & FILTER (K820091)James L. Geraci & Associates, Inc.1982-02-24
EMIT FREELEVEL SYSTEM I (K820224)Syva Co.1982-02-23
SIGMA 2000 GAS CHROMATOGRAPH (K820283)The Perkin-Elmer Corp.1982-02-23
RAICHEM GOT (AST) REAGENT (K820270)Reagents Applications, Inc.1982-02-18
4050/4051 ULTRASPEC (K820273)Lkb Instruments, Inc.1982-02-18
BI-LEVEL ASSAYED URINE METAL CONTROL (K820255)Ortho Diagnostic Systems, Inc.1982-02-18
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K820263)Eastman Kodak Company1982-02-18
TRACE ANALYTICAL REDUCTION GAS ANALYZ (K820025)Trace Analytical1982-02-15
ULTRAZYME PLUS GAMMA GT(65055-65056) (K820233)Harleco1982-02-12
LKB-WALLACE 1251 LUMINOMETER (K820217)Lkb Instruments, Inc.1982-02-12
WAKO CALCIUM C TEST (K820241)Wako Chemicals USA, Inc.1982-02-12
TPTZ CHLORIDE (K820235)American Monitor Corp.1982-02-12
IMMU-COUNT (K820137)Kemble Instruments, Inc.1982-02-05
FSH RADIOIMMUNOASSAY TEST SYSTEM (K820048)Monobind1982-02-04
ELECTROLYTE ANALYZER ACCESSORY (K820118)Boehringer Mannheim Corp.1982-02-04
LIQUIZYME CREATININE REAGENT SET (K813560)Amresco, Inc.1982-01-29
ALKALINE PHOSPHATASE REAGENT SET (K812837)Anco Medical Reagents & Assoc.1982-01-29
TSH (RIA) KIT (K820089)Immuno Assay Corp.1982-01-28
ASTRA-T CALCIUM REAGENT (K820090)Hi Chem, Inc.1982-01-28
CORTISOL (RIA) KIT (K820074)Immuno Assay Corp.1982-01-28
PATHWAY PH BLOOD GAS CONTROL (K820103)Beckman Instruments, Inc.1982-01-28
MODEL 5790 GAS CHROMATOGRAPH (K820071)Hewlett-Packard Co.1982-01-28
SERALYZER CREATININE REAGENT STRIPS (K820075)Miles Laboratories, Inc.1982-01-26
IL 703, STAT SEPARATOR (K812750)Instrumentation Laboratory CO1982-01-26
LEECO PRL-QUANT DIAGNOSTIC TEST KIT (K820039)Leeco Diagnostics, Inc.1982-01-22
POTASSIUM REAGENT SET (K813608)Diagnostic Specialties1982-01-22
SODIUM & POTASSIUM PRODUCTS (K813127)Alko Diagnostic Corp.1982-01-22
MICROMEDIC HTSH RIA KIT (K813645)Micromedic Systems1982-01-22
ABBOTT PAP-EIA (K812925)Abbott Laboratories1982-01-19
CARDIOTRAC CORNING CK ISOENZYME SUBST (K813573)Corning Medical & Scientific1982-01-18
GLUCOSE ENZYME-COLOR REAGENT SET (K813555)Biorent Diagnostic, Inc.1982-01-18
Q-LINE LTC (K813580)Miles Laboratories, Inc.1982-01-18
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT (K812768)Diagnostic Products Corp.1982-01-18
LIQUID CHROMATOGRAPHY (HPLC) COLUMNS (K813575)Supelco, Inc.1982-01-18
DADE COLORIMETRIC AMYLASE (K813529)American Dade1981-12-31
GLUCOSE ENZYME-COLOR REAGENT SET (K813412)Diagnostic Specialties1981-12-31
ALT (SGPT) (K813495)Pointe Scientific, Inc.,1981-12-31
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR (K813447)Rna Medical Corp.1981-12-31
A FLUOROMETER (K813540)American Diagnostic Corp.1981-12-31
UREA NITROGEN REAGENT SET (K813415)Anco Medical Reagents & Assoc.1981-12-31
FLAME PHOTOMETER CALIBRATION STANDARDS (K813505)Fisher Scientific Co., LLC1981-12-31
ASTRA TOTAL PROTEIN REAGENT (K813536)Hi Chem, Inc.1981-12-31
PHE/TYR KINETIC UV TEST SET (K813449)P-L Biochemicals, Inc.1981-12-31
ELECTRIC SELF STERILIZATION INOCUL. LOOP (K813523)Techhnilab Instruments, Inc.1981-12-31
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