Clinical Chemistry
13,051 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| KODAK EKTACHEM ELECTROLYTE ANALYZER (K800054) | Eastman Kodak Company | 1980-02-05 |
| BUN REAGENT KIT (K800071) | Fisher Scientific Co., LLC | 1980-02-05 |
| ASI REAGENT (K800065) | Gilford Diagnostics | 1980-02-05 |
| MICROPITETTE (K792696) | Meridian Diagnostics, Inc. | 1980-02-01 |
| CORTEX DOUBLE HELIX SAMPLER (K800003) | Cortex Research Corp. | 1980-02-01 |
| ALKALINE PHOSPHATASE REAGENT (K792551) | Electrophoresis Corp. of America | 1980-01-29 |
| URIC ACID KIT (K792545) | Alta Diagnostics, Inc. | 1980-01-29 |
| LDC CONSTAMETRIC III HIGHT PRESS. SOL. (K800048) | Laboratory Data Control | 1980-01-29 |
| ALKALINE PHOSPHATASE MARKER (K792548) | Electrophoresis Corp. of America | 1980-01-29 |
| AGAROSE BARBITAL-EDTA BUFFER (K792553) | Electrophoresis Corp. of America | 1980-01-29 |
| AGAROSE BARBITAL BUFFER (K792547) | Electrophoresis Corp. of America | 1980-01-29 |
| H-I-M-TEST FOR DETECTING HUMAN CHOR. GON (K800055) | Technam, Inc. | 1980-01-29 |
| DELTA TEST AMYLASE UV (K800049) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-01-23 |
| KODAK EKTACHEM FOUR CHEMISTRY ANALYZER (K800053) | Eastman Kodak Company | 1980-01-23 |
| QUANTIMUNE CORTISOL RIA CORTISOL RADIO- (K800045) | Bio-Rad | 1980-01-23 |
| LITHIUM STANDARD (1MM/L) (K800042) | Gilford Diagnostics | 1980-01-21 |
| ALT REAGENT (K800038) | Gilford Diagnostics | 1980-01-21 |
| CESIUM DILUENT (1.5 MM/L) (K800043) | Gilford Diagnostics | 1980-01-21 |
| BLOOD FLUID FILTERS (K792723) | Dade, Baxter Travenol Diagnostics, Inc. | 1980-01-21 |
| SODIUM/POTASSIUM 140/5 MEQ/L) (K800041) | Gilford Diagnostics | 1980-01-21 |
| LDC UVIII FIXED WAVELENGTH ULTRAVIOLET (K800047) | Laboratory Data Control | 1980-01-21 |
| WORTHINGTON FLOZYME* CPK (340NM) (K800028) | Worthington Diagnostic Systems | 1980-01-21 |
| SODIUM/POTASSIUM (100/100 MEQ/E) (K800040) | Gilford Diagnostics | 1980-01-21 |
| DUPONT ACA ION SELECTIVE ELECTRODE (K800016) | E.I. Dupont DE Nemours & Co., Inc. | 1980-01-21 |
| PENTEX LIPOPROTEIN CHOLESTEROL SOLU. (K800035) | Miles Laboratories, Inc. | 1980-01-21 |
| TOTAL ESTRIOL RIA KIT (K800036) | Amersham Corp. | 1980-01-21 |
| CENTRIA FSH RIA (K792233) | Union Carbide Corp. | 1980-01-21 |
| COBAS-BLO REAGENTS (LACTATE DEHYDRO (K792658) | Hoffmann-La Roche, Inc. | 1980-01-17 |
| ANALYTE CORTISOL (K792439) | Technicon Instruments Corp. | 1980-01-17 |
| VENOJECT AUTOSEP (K792587) | Kimble-Terumo, Inc. | 1980-01-17 |
| AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM (K792662) | Micromedic Systems | 1980-01-17 |
| COBAS-BIO CENTRIFUGAL ANALYZER (K792671) | Hoffmann-La Roche, Inc. | 1980-01-17 |
| RIA-QUANT CK-MB TEST KIT (K792504) | Mallinckrodt Critical Care | 1980-01-16 |
| ELVI MUCAPROTEINS (K792554) | Volu Sol Medical Industries | 1980-01-16 |
| CHLORIDE REAGENT (K792605) | Gilford Diagnostics | 1980-01-16 |
| ELVI NON-ESTERIFIED FATTY ACIDS (K792555) | Volu Sol Medical Industries | 1980-01-16 |
| NEOCHROME II GLUCOSE, #4044 (K792534) | American Monitor Corp. | 1980-01-16 |
| CK-MB (CREATINE KINASE-MB) RIA CONTROL (K792524) | Mallinckrodt Critical Care | 1980-01-16 |
| TRIIODOTHYRONINE RIA SYSTEM (K792539) | Radioimmunoassay, Inc. | 1980-01-16 |
| T3 UPTAKE (T3U) REAGENTS (K792607) | Dade, Baxter Travenol Diagnostics, Inc. | 1980-01-16 |
| CENTRIA LH RIA (K792350) | Union Carbide Corp. | 1980-01-16 |
| SENSI-SLIDE (K792657) | Hoffmann-La Roche, Inc. | 1980-01-16 |
| SPECTROPHATOMETER MODELS 2280 & 2380AA (K792557) | The Perkin-Elmer Corp. | 1980-01-16 |
| TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY (K792599) | Nuclear Diagnostics, Inc. | 1980-01-16 |
| LEECO P.A.P. QUANT. DIAGNOSTIC KIT (K792652) | Leeco Diagnostics, Inc. | 1980-01-16 |
| IMMUNOSTAT TSH TEST (K792562) | Meloy Laboratories, Inc. | 1980-01-16 |
| SANDARE CHLORIDE PROCEDURE (K792531) | Sandare Chemical Co., Inc. | 1980-01-11 |
| GLUCOSE (HEXOKINASE) REAGENT SET (K792532) | Macomb Chemical Co. | 1980-01-11 |
| CHEMISTRY ANALYZER REAGENTS (K792482) | Laboratory Products, Inc. | 1980-01-11 |
| ACA HIGH DENSITY LIPOPROTEIN CHOLES. (K792509) | E.I. Dupont DE Nemours & Co., Inc. | 1980-01-11 |
| CREATINE PHOSPHOKINASE (CPK) REAGENT SET (K792533) | Macomb Chemical Co. | 1980-01-11 |
| SERACON-SRI (PROD. # D029 (K792486) | Bhp Diagnostix, Inc. | 1979-12-31 |
| AVL MODEL 940 AUTOMATIC PH/BLOOD GAS (K792230) | Gauntlet Technology Corp. | 1979-12-31 |
| SERACON-SRI (K792485) | Bhp Diagnostix, Inc. | 1979-12-31 |
| SERACON-SRII (K792487) | Bhp Diagnostix, Inc. | 1979-12-31 |
| CHEM-STRATE AMYLASE (K792479) | General Diagnostics | 1979-12-27 |
| TIPSEP-T3U TRIIODOTHYRONINE UPTAKE (K792484) | Nuclear Diagnostics, Inc. | 1979-12-27 |
| SYSTEM 103 CHEMISTRY ANALYZER (K792361) | Gilford Instrument Laboratories, Inc. | 1979-12-27 |
| CHEM-STRATE CK-NAC (K792477) | General Diagnostics | 1979-12-27 |
| TSH RADIOIMMUNOASSAY (K792443) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-12-27 |
| CHEM-STRATE TRIGLYCERIDE (K792480) | General Diagnostics | 1979-12-27 |
| REFEREE BFT BLOOD FOR TONOMETRY (K792447) | Analytical Products, Inc. | 1979-12-27 |
| CHEM-STRATE CHOLESTEROL (K792478) | General Diagnostics | 1979-12-27 |
| STATTEK BUN (K792328) | Boehringer Mannheim Corp. | 1979-12-18 |
| CONNECTICUT DIAGNOSTICS, LTS. DIRECT (K792465) | Connecticut Diagnostics, Ltd. | 1979-12-18 |
| LIPASE TEST KIT (K792289) | Mallinckrodt Critical Care | 1979-12-18 |
| S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO (K792059) | S.F. Biologicals, Inc. | 1979-12-13 |
| CHOL-HDL TEST, HIGH LIPO. CHOL TEST (K792313) | Sclavo, Inc. | 1979-12-07 |
| ELVI CREATININ (K792402) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI ACID & PROSTATIC PHOSPHATASE (K792405) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI GLUCOSE (K792398) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI TOTAL BILIRUBIN & FRACTIONS (K792415) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI CREATININE (K792404) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI TRIGLYCERIDE (K792414) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI CHLORIDE (K792400) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI TOTAL PROTEINS (K792416) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI INORGANIC PHOSPHOROUS (K792401) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI MAGNESIUM (K792399) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI URIC ACID (K792412) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI BLOOD UREA NITROGEN (K792417) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI SERUM IRON (K792406) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI CREATININE (K792397) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI ALKALINE PHOSPHATATASE (K792413) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI URIC ACID-COLORIMETRIC METHOD (K792403) | Volu Sol Medical Industries | 1979-12-07 |
| QUANTITATIVE CONTROL URINE I (HUMAN) (K792374) | Environmental Chemical Specialties | 1979-12-06 |
| BLOOD UREA NITROGEN REAGENT (K792362) | Connecticut Diagnostics, Ltd. | 1979-12-06 |
| PRINCIPAL ANALYTE REFERENCE SERUM (K792384) | Beckman Instruments, Inc. | 1979-12-06 |
| ELEVATED LIPID CONTROL (K792375) | Environmental Chemical Specialties | 1979-12-06 |
| CENTRIA CORTISOL RIA TEST SET (K792243) | Ventrex Laboratories, Inc. | 1979-12-06 |
| TSH STANDARDS & DILUENT (K792290) | Amersham Corp. | 1979-12-06 |
| ELVI TOTAL BILIRUBIN & FRACTIONS (K792411) | Volu Sol Medical Industries | 1979-12-06 |
| CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE (K792340) | Connecticut Diagnostics, Ltd. | 1979-12-06 |
| DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS (K792338) | Connecticut Diagnostics, Ltd. | 1979-12-06 |
| ELVI TOTAL IRON BINDING CAPACITY (K792409) | Volu Sol Medical Industries | 1979-12-06 |
| ELVI CALCIUM (K792396) | Volu Sol Medical Industries | 1979-12-06 |
| MICRO LOWRY PROTEINTEST (K792347) | Panmed, Inc. | 1979-12-06 |
| TWO MINUTE PROTEINTEST (K792346) | Panmed, Inc. | 1979-12-06 |
| CONCEP-7-BHCG (K792308) | Leeco Diagnostics, Inc. | 1979-12-06 |
| DONNECT. DIAG. CALCIUM DIAG. REAGENT (K792337) | Connecticut Diagnostics, Ltd. | 1979-12-06 |
| ELVI ALBUMIN (K792408) | Volu Sol Medical Industries | 1979-12-06 |
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