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Clinical Chemistry

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

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RecordFirmDate
SANDARE FAST 340 PHOSPHORUS PROCEDURE (K812670)Sandare Chemical Co., Inc.1981-10-02
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO (K812611)Kallestad Laboratories, Inc.1981-10-02
THYROXINE (T4) 125I (K812666)Pcl-Ria, Inc.1981-10-02
ULTRA ZYME PLUS AMYL #64982 & 65031 (K812594)Harleco1981-10-02
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 (K812593)Harleco1981-10-02
EMBRITROL CK-MB CONTROLS (K812671)Intl. Immunoassay Laboratories, Inc.1981-10-02
BIOVATION URINALYSIS REPORTER (K812604)Biovation, Inc.1981-10-02
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM (K812641)Reagents Applications, Inc.1981-10-02
UNITEST-POTASSIUM (K812677)Biodynamics Corp.1981-10-02
ULTRA CHEM E-GLU #64976 & 65040 (K812595)Harleco1981-09-29
ULTRA ZYME PLUS ALP #64962, 65029 & 30 (K812596)Harleco1981-09-29
ULTRA ZYME PLUS GOT #64953, 65033 & 34 (K812592)Harleco1981-09-24
ULTRA ZYME PLUS GPT, #64956, 65035 & 36 (K812591)Harleco1981-09-24
HDL CHOLESTEROL REAGENT (K812574)Pointe Scientific, Inc.,1981-09-24
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY (K812227)Clinical Assays, Inc.1981-09-24
BOVINE CHEMISTRY CONTROL I.X. & II.X. (K812583)American Dade1981-09-24
ULTRA ZYME PLUS LDH #64950, 65038 & 39 (K812590)Harleco1981-09-24
ULTRA CHEM E-TRIG #65024 (K812589)Harleco1981-09-24
AQUEOUS BLOOD GAS CONTROLS (K812553)Fisher Scientific Co., LLC1981-09-23
COROMETRICS MEDICAL SYST. 220 PH ANALY. (K812552)Transidyne General Corp.1981-09-23
PROTEIN-BASED BLOOD GAS CONTROL (K812541)American Dade1981-09-23
ULTRACHEM URIC ACID ALDH, ITEM #65047 (K812500)Harleco1981-09-23
PALL ULTIPOR VACUUM LINE BACTERIA FITLER (K812505)Pall Biomedical Products Co.1981-09-16
SPIN-CHEM LD-L REAGENT (K812472)Smithkline Diagnostics, Inc.1981-09-14
SPIN-CHEM TRIGLYCERIDES REAGENT (K812471)Smithkline Diagnostics, Inc.1981-09-14
ALKALINE PHOSPHATASE (K812452)Pointe Scientific, Inc.,1981-09-09
AMYLASE REAGENT KIT (K812447)Bioscientific1981-09-09
BLOOD UREA NITROGEN(BUN-UV) (K812417)Reagents Applications, Inc.1981-09-09
URIC ACID REAGENT SET (K812430)Pointe Scientific, Inc.,1981-09-09
J & S IRON SATURATING REAGENT (K811942)Thyroid Diagnostics, Inc.1981-09-08
GLUCOSE-HK SYSTEM PACK TEST (K812303)Boehringer Mannheim Corp.1981-09-01
UREA NITROGEN (BUN) (K812341)Pointe Scientific, Inc.,1981-09-01
B-NEOCEPT (K812334)Organon, Inc.1981-09-01
REAGENT STRIPS FOR URINALYSIS (K811342)Miles Laboratories, Inc.1981-09-01
TANDEM PAP KIT - (PARTS I & II) (K811959)Hybritech, Inc.1981-09-01
SANDARE URIC ACID PROCEDURE (K812313)Sandare Chemical Co., Inc.1981-09-01
ACCURATE I (K812261)Organon, Inc.1981-08-31
ENXYMATIC CREATININE TEST (K812095)Boehringer Mannheim Corp.1981-08-31
GAMMA GLUTAMY TRANSPEPTIDASE (K812296)Pointe Scientific, Inc.,1981-08-31
ACR ENZYMATIC GLUCOSE OXIDASE (K812258)Harleco1981-08-31
LANCER BUN RATE REAGENT KIT (K812308)Sherwood Medical Co.1981-08-31
CENTRICHEM CHOLESTEROL REAGENT & CALIBRA (K812293)Baker Diagnostics1981-08-31
FUN-UV SYSTEM PACK TEST (K812290)Boehringer Mannheim Corp.1981-08-31
HUMAN C-PEPTIDE REAGENTS (K812288)Immunex Radiochemical Diagnostics1981-08-31
TRYPIN (125I) RIA KIT (K811805)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-08-31
MONOJECT STERILE CORVAC BLOOD TUBE (K812285)Sherwood Medical Co.1981-08-31
COAT-A-COUNT T3 RIA KIT (K812246)Diagnostic Products Corp.1981-08-20
CONCEP-7-BHCG (K812156)Leeco Diagnostics, Inc.1981-08-20
URIC ACID REAGENT SET (K811764)Anco Medical Reagents & Assoc.1981-08-20
NEPHELOMETRIC SOLID TURBIDITY STANDARD (K812220)Hyland Therapeutic Div., Travenol Laboratories1981-08-18
GILCHEM CALCIUM REAGENT (K812110)Gilford Diagnostics1981-08-13
GILCHEM CREATININE REAGENT (K812109)Gilford Diagnostics1981-08-13
CREATININE RATE REAGENT KIT (K811406)Chem-Elec, Inc.1981-08-13
MARRIA-HPRL RIA KIT (K812112)Intl. Immunoassay Laboratories, Inc.1981-08-13
AMERLEX TSH RIA KIT (K812136)Amersham Corp.1981-08-13
ASTRA (K811381)Chem-Elec, Inc.1981-08-13
CHLORIDE REAGENT KIT (K811319)Chem-Elec, Inc.1981-08-13
GLUCOSE OXIDASE RATE REAGENT (K811165)Chem-Elec, Inc.1981-08-13
NEIA PAP ENZYMEIMMUNOASSAY (K811757)New England Immunology Assoc.1981-08-13
SERALYZER (K812100)Miles Laboratories, Inc.1981-08-12
FAST CHOLES-CINET (K812091)Sclavo, Inc.1981-08-12
WAKO NEFA C TEST (K812081)Wako Chemicals USA, Inc.1981-08-12
OREIA II, B-HCG (K811940)Organon, Inc.1981-08-03
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) (K812029)Eastman Kodak Company1981-08-03
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) (K812030)Eastman Kodak Company1981-08-03
RADIOIMMUNOASSAY, FOLLICLE STIMULATING (K811993)Endocrine-Metabolic Center1981-08-03
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) (K812028)Eastman Kodak Company1981-08-03
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) (K812027)Eastman Kodak Company1981-08-03
SIGMA PROCEDURE 265-UV (K811864)Sigma Chemical Co.1981-07-31
GASTRIN RIA DIAGNOSTIC KIT (K812004)Abbott Laboratories1981-07-28
RADIOIMMUNOASSAY LUTEINIZING HORMONE (K811994)Endocrine-Metabolic Center1981-07-27
NEOCEPT (K811941)Organon, Inc.1981-07-27
MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL (K811975)Waters Assoc., Inc.1981-07-27
COMBO-FER IRON DIAGNOSTIC (K811954)Immuno Assay Corp.1981-07-27
KING DIAGNOSTICS GLUCOSE TEST (K811882)King Diagnostics, Inc.1981-07-23
HITACHI 705 CALIBRATOR (K811921)Boehringer Mannheim Corp.1981-07-23
CESIUM DILUENT 7.5M (K811886)Gilford Diagnostics1981-07-23
KODAK EKTACHEM 400 ANALYZER (K811919)Eastman Kodak Company1981-07-23
ACCUDEX (K811680)Biodynamics Corp.1981-07-23
KING DIAGNOSTICS GLUCOSE-O TEST (K811883)King Diagnostics, Inc.1981-07-23
UROPAPER EIKEN UAG (K811818)Syn-Kit, Inc.1981-07-23
ESKAFLOW TEST FOR TRIGLYCERIDES (K811850)Smithkline Diagnostics, Inc.1981-07-23
DHEA-SULFATE DIRECT RIA KIT(125I) (K811906)Immunalysis Corporation1981-07-23
HELENA VMA-SMC CONTROL (K811912)Helena Laboratories1981-07-23
902 NA/K (K811896)Corning Medical & Scientific1981-07-23
KING DIAGNOSTICS TOTAL BILIRUBIN TEST (K811881)King Diagnostics, Inc.1981-07-23
IMMOPHASE INSULIN (125I) RADIOASSAY (K811953)Corning Medical & Scientific1981-07-23
PROGESTERONE DIRECT RIA KIT (125I) (K811907)Immunalysis Corporation1981-07-23
FOLLICLE STIMULATING HORMONE DIRECT RIA (K811905)Immunalysis Corporation1981-07-23
QUICK-CHEM COLORIMETER (K811806)The Dow Chemical Co.1981-07-15
BILIRUBINOMETER (K811840)Advanced Instruments, Inc.1981-07-15
UROPAPER EIKEN AG (K811817)Syn-Kit, Inc.1981-07-15
PRECINORM U & PRECIPATH U HUMAN SERUM (K811832)Boehringer Mannheim Corp.1981-07-15
ESKAFLOW TEST FOR GLUCOSE (K811849)Smithkline Diagnostics, Inc.1981-07-15
URIC ACID TEST (K811810)Environmental Chemical Specialties1981-07-15
QUANTAPHASE T-4 RIA (K811787)Bio-Rad1981-07-10
KING DIAGNOSTICS CHOLESTEROL-FE TEST (K811746)King Diagnostics, Inc.1981-07-10
HCG RADIOIMMUNOASSAY KIT (125I) (K811421)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-07-10
CHOLESTEROL DETERMINATION (K811760)Biorent Diagnostic, Inc.1981-07-10
SODIUM/POTASSIUM REAGENT KITS (K811310)Chem-Elec, Inc.1981-07-10
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