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Clinical Chemistry

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

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RecordFirmDate
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE (K831242)American Dade1983-05-16
EZEE FILTER/SEPARATOR (K831081)The Kendall Company Div. of Tyco Healthcare Group1983-05-16
CORDIA PAP (K831105)Cordis Corp.1983-05-16
EXTRELUT QE EXTRACTION COLUMNS (K831027)Emd Chemicals, Inc.1983-05-16
HELENA BIOSTRIP A (K830978)Helena Laboratories1983-05-13
CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK (K830563)Sorin Biomedica, Fiat, USA, Inc.1983-05-13
BUFFER PACK FOR ABL-1 & ABL-2 (K831017)Fisher Scientific Co., LLC1983-05-09
HUMAN INTRACT PARATHYROID HORMONE BY (K830664)Immuno Nuclear Corp.1983-05-09
PHASE II T3 RADIOIMMUNOASSAY KIT (K831064)Medical & Scientific Designs, Inc.1983-05-09
COBAS STANDARDS FOR GLUCOSE & BUN (K831030)Roche Diagnostic Systems, Inc.1983-05-09
FLUSH SOLUTION CONCENTRATE (K831020)Fisher Scientific Co., LLC1983-05-09
DIAGNOSTICS PO2 ELECTRODE CLEANER (K831010)Fisher Scientific Co., LLC1983-05-05
HELENA BIOSTRIP PH (K830979)Helena Laboratories1983-05-05
BATH CLEAR (K831016)Fisher Scientific Co., LLC1983-05-05
BTC URINE LCG ASSAY (K831125)Btc Diagnostics, Inc.1983-05-05
HELENA BIOSTRIP K (K830976)Helena Laboratories1983-05-04
FLOW-PAC SGPT REAGENT (K830959)Amresco, Inc.1983-05-04
PLAN A LIFE (K830975)New Directions Co.1983-05-04
FLOW-PAC SGOT REAGENT (K830958)Amresco, Inc.1983-05-04
HELENA BIOSTRIP P (K830977)Helena Laboratories1983-04-28
VENTREX ENZYME TSH KIT (K830928)Ventrex Laboratories, Inc.1983-04-28
I.E.C COLUMN (K830918)Berwick Medical Products, Inc.1983-04-27
POTASSIUM ANALYZER-SODIUM/ELECTROLYTE (K830588)Shaban Mfg. Co.1983-04-27
ACTH RIA SYSTEM-DSI 2300 (K830893)Diagnostic Systems Laboratories, Inc.1983-04-27
ELECTROLYTE STANDARD - CORNING NALK ISE (K830589)Shaban Mfg. Co.1983-04-27
IMMO PHASE DIRECT PROGESTERONE RADIO- (K830880)Corning Medical & Scientific1983-04-18
NUCLIPASE (I125) PANCREATIC LIPASE (K823860)Nuclear Diagnostics, Inc.1983-04-18
UPTAKE T3 RADIOIMMUNOASSAY KIT (K830900)Medical & Scientific Designs, Inc.1983-04-18
WAKO FREE CHOLESTEROL C TEST (K830761)Wako Chemicals USA, Inc.1983-04-18
PROTOPORPHYRIN ZN CONTROL (K830493)Kaulson Laboratories, Inc.1983-04-18
QUANTIMETRIX BROMERESOL PURPLE ALBUMIN (K830934)Quantimetrix Corp.1983-04-18
TITAN GEL LDH ISO-ENZYME CONTROL (K830872)Helena Laboratories1983-04-12
DSL 1900 (K830816)Diagnostic Systems1983-04-12
OLYMPUS HIGH SPEED ANALYZER (K830762)Olympus Corp.1983-04-12
INDUCTIVELY-COUPLED PLASMA SPECTROMETER (K830799)The Perkin-Elmer Corp.1983-04-12
NEGATIVE URINE CONTROL (K830834)Helena Laboratories1983-04-12
TDX T-UPTAKE (K830912)Abbott Laboratories1983-04-12
CYNOX I HEMOGLOBINOMETER (K830569)Buffalo Medical Specialties Mfg., Inc.1983-04-08
LEECO T3-RIA DIAGNOSTIC KIT (K830808)Leeco Diagnostics, Inc.1983-04-08
MMH PTH RIA KIT (K830700)Diagnostic Systems1983-04-06
URIC ACID COLORIMETRIC DETERMINATION (K830679)Dow Instruments & Reagents, Inc.1983-04-06
TDX THYROXINE (K830683)Abbott Laboratories1983-04-06
KEMTEK 102 (K830751)Kemble Instruments, Inc.1983-04-06
TOTAL BILIRUBIN REAGENT (K830714)Hi Chem, Inc.1983-04-06
ACTIVATED URIC ACID (K830616)American Monitor Corp.1983-04-05
ENCORE CHEMISTRY ANALYZER (K830641)Baker Instructions Corp.1983-04-05
FLUOROMETER, GENERAL USE (K830624)Abbott Diagnostics1983-04-05
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM (K830213)Nova Biomedical Corp.1983-04-05
RADIOIMMUNOASSAY TEST SYSTEM PRL (K830412)Monobind1983-04-05
B-GCG SYSTEM BY RIA (K830526)Pcl-Ria, Inc.1983-04-05
ELISA PLUS SYSTEM (K830212)William-Palmer Industries, Inc.1983-04-05
FEKAL CON-TRATE SYSTEM (K830769)Trend Scientific, Inc.1983-04-05
CREATINE KINASE REAGENT SET (K830672)Sterling Biochemical, Inc.1983-04-05
ULTRA CHEM BUN-UV #65080-65081 (K830241)Emd Chemicals, Inc.1983-04-05
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA (K830239)Emd Chemicals, Inc.1983-04-05
DUPONT PREP TYPE AS EXTRACTION CARTRIDE (K830693)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
LEECO TESTOSTERONE DIAGNOSTIC KIT (K830512)Leeco Diagnostics, Inc.1983-04-05
DUPONT PREP OD EXTRACTION CARTRIDE (K830692)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
PHASE THYROXINE RADIOIMMUNOASSAY KIT (K830642)Medical & Scientific Designs, Inc.1983-04-05
PHADEBAS HUMYLASE CONTROL(H) (K823421)Pharmacia, Inc.1983-04-05
AUTO PREP (K830319)Pm America, Inc.1983-03-29
BETA-COTE B-HCG PREGNANCY SCREENING SYS (K830695)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-03-29
FEB TEST (K830564)Wako Chemicals USA, Inc.1983-03-29
CORNING 102 PRINTER (K830296)Corning Medical & Scientific1983-03-25
FLOW-PAC CREATININE REAGENT SET (K830537)Amresco, Inc.1983-03-24
FLOW-PAC ALKALINE PHOSPHATE REAGENT SET (K830535)Amresco, Inc.1983-03-24
BILIRUBIN STANDARD-LYOPHILIZED (K830469)Dow Instruments & Reagents, Inc.1983-03-24
AMRESCO UREA NITROGEN REAGENT SET (K830555)Amresco, Inc.1983-03-24
CREATININE (K830556)Pointe Scientific, Inc.,1983-03-24
FLOW-PAC ALBUMIN REAGENT (K830536)Amresco, Inc.1983-03-24
KINETIC CREATININE (K830447)American Monitor Corp.1983-03-24
FLOW-PAC TOTAL PROTEIN REAGENT SET (K830538)Amresco, Inc.1983-03-24
NOVA 8 IONIZED CALCIUM/PH ANALYZER (K830502)Nova Biomedical Corp.1983-03-24
RAICHEM HDL-CHOLESTEROL REAGENT (K830207)Reagents Applications, Inc.1983-03-21
DIGIFLEX AUTOMATIC PIPETTE (K830157)Micromedic Systems1983-03-10
KINETI COUNT 48 IMMUNOASSAY SYSTEM (K830365)Medical & Scientific Designs, Inc.1983-03-10
NO-BOIL SOLID PHASE SIMUL TRAC B12 (K822721)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-03-10
SALT BRIDGE SOLUTION & URINE DILUENT (K830341)Shaban Mfg. Co.1983-03-10
PARAMAX ANALYTICAL SYS (K830318)American Dade1983-03-07
MR 600 MICROPLATE READER (K823512)Laboratory and Medical Products Group1983-03-01
LITHIUM DILUENT (K830283)Shaban Mfg. Co.1983-02-28
REFEREE BLOOD GAS ANALYZER CONTROLS (K830181)Analytical Products, Inc.1983-02-28
MANUALISA MICROTITRATION PLATE READER (K823590)Ortho Diagnostic Systems, Inc.1983-02-28
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE (K830309)Emd Chemicals, Inc.1983-02-28
ULTRA ZYME PLUS GAMMA GT #65055 & 56 (K830308)Emd Chemicals, Inc.1983-02-28
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE (K830118)Corning Medical & Scientific1983-02-25
STRATUS FLUOROMETRIC ENZYME IMMUN0- (K830301)American Hospital Supply Corp.1983-02-25
TRIGLYCERIDE DIAGNOSTIC KIT (K830288)Sclavo, Inc.1983-02-25
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 (K830240)Emd Chemicals, Inc.1983-02-18
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID (K830195)Diagnostic Products Corp.1983-02-18
BIOCELL SPINAL FLUID CONTROL (K830179)Biocell Laboratories, Inc.1983-02-18
BLOOD GAS INCUBATOR #260650 (K823766)Boekel Industries, Inc.1983-02-18
DAC-CEL DIAGNATAL HCG STANDARDS RD49 (K830204)Wellcome Diagnostics1983-02-18
ULTRA CHEM CRESOLCAVERSACHEM #65082 (K830238)Emd Chemicals, Inc.1983-02-18
DAC-CEL DIAGNATAL RD 50 (K830203)Wellcome Diagnostics1983-02-18
CAST SHOE, CAST BOOT (K830246)Warm & Form, Orthopedic Materials1983-02-18
REAGENTS CORNING CHLORIDE METER FOR (K830217)Fisher Scientific Co., LLC1983-02-18
LITH A TEST TM (K830091)Lenal Creative Approaches, Inc.1983-02-15
HCG SCREENING TEST (K830156)Tago, Inc.1983-02-09
APSARA CLINICAL DIAG. & INFO. SYS (K823386)Datachem, Inc.1983-02-09
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