Clinical Chemistry
13,051 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| CHLORIDE REAGENT (K781460) | Analytical & Research Chemicals, Inc. | 1978-10-10 |
| ANTIBIOTIC NEPHELOMETER (K781644) | Biovation, Inc. | 1978-10-03 |
| BECKMAN ASTRA SYSTEM (K781442) | Beckman Instruments, Inc. | 1978-10-03 |
| ACID PHOSPHATASE DIAG. KIT (K781489) | Sclavo, Inc. | 1978-10-03 |
| AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT (K781466) | Fisher Scientific Co., LLC | 1978-10-03 |
| MINI-KEM (K781576) | Coulter Electronics, Inc. | 1978-10-03 |
| SINGLE VIAL LDH-L TRIS (K781538) | Boehringer Mannheim Corp. | 1978-10-03 |
| STAT ULTRA VIOLET LIQUID (K781432) | Beckman Instruments, Inc. | 1978-10-03 |
| ENZAC INCUBATOR (K781501) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-03 |
| SMA/GGT (K781533) | Technicon Instruments Corp. | 1978-10-03 |
| CHLORIDE TEST SET, CAT.# 0210 (K781635) | Stanbio Laboratory | 1978-10-03 |
| EPPENDORF PCP 6121 (K781544) | Marilyn L. Amick | 1978-10-03 |
| MEPA-1 BLOOD ANALYZER (K781606) | Medico Electronic, Inc. | 1978-10-03 |
| TRIGLYCERIDES TEST KIT (K781477) | Mallinckrodt Critical Care | 1978-10-03 |
| EMIT MCA PROGRAM TAPE (K781081) | Instrumentation Laboratory CO | 1978-09-27 |
| IMMO PHASE, THYROID HORMONE (K781409) | Corning Medical & Scientific | 1978-09-27 |
| ORTHO*T-3 UPTAKE KIT (K781482) | Ortho Diagnostics, Inc. | 1978-09-27 |
| TECHNICON STAT/LYTE ISE ELECTROLYTE (K781503) | Technicon Instruments Corp. | 1978-09-27 |
| ORTHO*T-3 RIA (PEG) KIT (K781481) | Ortho Diagnostics, Inc. | 1978-09-27 |
| MITROPHENYL, ALKALINE PHOSPHATES (K781472) | Beckman Instruments, Inc. | 1978-09-27 |
| RIALYZE VITAMIN B-12 TEST (K781410) | Ames Div., Miles Laboratories, Inc. | 1978-09-27 |
| COULTER ELECTROLYTE ANALYZER SYSTEM (K781528) | Coulter Electronics, Inc. | 1978-09-27 |
| ORTHO*T-4 RIA (PEG) KIT (K781483) | Ortho Diagnostics, Inc. | 1978-09-27 |
| LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA (K781454) | Union Carbide Corp. | 1978-09-20 |
| BIOSCAN E12 (K781421) | Clinifax Industries, Ltd. | 1978-09-20 |
| PRECISION GAS MIXER (K781417) | Medicor USA , Ltd. | 1978-09-20 |
| CEA-IMMERSIBLE SEPARATOR (K781043) | Millipore Corp. | 1978-09-15 |
| MODEL 5000, LIQUID CHROMATOGRAPHY (K781379) | Varian Assoc., Inc. | 1978-09-14 |
| CREATININE REAGENT SET (K781396) | Nobel Scientific Industries, Inc. | 1978-09-14 |
| COMPUTER INTERFACE IL 814 (K781173) | Instrumentation Laboratory CO | 1978-09-14 |
| EBS 775 TONOMETER (K781386) | Equilibrated Bio Systems, Inc. | 1978-09-14 |
| SYSTEM 6000 AUTOMATED RIA ANALYZER (K780886) | Beckman Instruments, Inc. | 1978-09-01 |
| HUMAN CHORIONIC GONADO.-BETA RIA KIT (K781310) | Diagnostics Biochem Canada, Inc. | 1978-08-31 |
| GLOBULIN TEST, HUMAN THYROXINE BINDING (K781225) | Hyland Therapeutic Div., Travenol Laboratories | 1978-08-31 |
| GLUCOLOUR (K781308) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| RABBIT ANTIBODY TO HUMAN T3 (K781284) | Pcl-Ria, Inc. | 1978-08-31 |
| ALP TEST (K781324) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| THYRO-SHURE (K781296) | Nuclear Medical Laboratories, Inc. | 1978-08-31 |
| UREA NITROGEN (K781305) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| UREA NITROGEN TEST KIT (K781306) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| GLUCOSE TEST (K781342) | Wako Intl., Inc. | 1978-08-31 |
| DUAL COMPONENT STANDARDS (K781423) | Abbott Laboratories | 1978-08-31 |
| GLUCOSE DETERM. KIT (K781307) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| CHLORIDE/CARBON DIOXIDE REAGENT SET (K781275) | Nobel Scientific Industries, Inc. | 1978-08-31 |
| DATA TERMINAL MODEL 722 (K781217) | Corning Medical & Scientific | 1978-08-21 |
| BUN (UREASE) REAGENT (K781253) | Coulter Electronics, Inc. | 1978-08-21 |
| ENZYMATIC TRIGLYCERIDES REAGENT KIT (K781240) | J.T. Baker Chemical Co. | 1978-08-17 |
| QUICKRATE REACTION RATE ANALYZER (K780972) | Olympus Corp. | 1978-08-14 |
| MICRO THYROXINE REAGENT SYSTEM (K781182) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 |
| QUANTIMUNE HTSH IRMA HUMAN THYROID (K781170) | Bio-Rad | 1978-08-14 |
| T3 STANDARDS IN HUMAN SERUM (K781069) | Pcl-Ria, Inc. | 1978-08-14 |
| STANDARDS, HORMONE, THYROID STIMULATING (K781071) | Pcl-Ria, Inc. | 1978-08-14 |
| SPECTROPHOTOMETER (K781138) | Bausch & Lomb, Inc. | 1978-08-14 |
| UNISTAT BILIRUBINOMETER (K781241) | American Optical Corp. | 1978-08-14 |
| CLINIRIA TOTAL T-4 (RIA) TEST (K781181) | Miles Laboratories, Inc. | 1978-08-14 |
| INSULIN RIA KIT (K781285) | Serono Laboratories, Inc. | 1978-08-14 |
| STATTEK-GLUCOSE LOW LEVEL (K781075) | Boehringer Mannheim Corp. | 1978-08-14 |
| CLINIRIA T-3 UPTAKE TEST (K781180) | Miles Laboratories, Inc. | 1978-08-14 |
| CHEMISTRY ANALYZER (K781076) | Johns Scientific, Inc. | 1978-08-14 |
| CPK-L TUBE (K781149) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 |
| INSULIN AUTOPAK (K781086) | Micromedic Systems | 1978-08-14 |
| DELTA TEST AMYLASE/LIPASE CONTS. I,II (K781100) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 |
| IV VITRO GAMMADAB T4 RIA KIT (K781235) | Clinical Assays, Inc. | 1978-08-14 |
| HDL CENTRIFIKIT (K781093) | Beckman Instruments, Inc. | 1978-08-14 |
| CONJUGATED BILE ACIDS RIA KIT (K781337) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-11 |
| ECA PREP (K781117) | Electrophoresis Corp. of America | 1978-08-10 |
| CHEMLAR (K781132) | Hi Chem, Inc. | 1978-08-10 |
| TRAP-BLOOD VESSEL STABILIZATION DEVICE (K781072) | Ayer, Patrick, M.D. | 1978-08-10 |
| TRICHLORACETIC ACID 7.5% (K781120) | Electrophoresis Corp. of America | 1978-08-10 |
| LDH (UV KINETIC) (K781128) | Macomb Chemical Co. | 1978-08-10 |
| ECA BUFFER, PH 816 (K781116) | Electrophoresis Corp. of America | 1978-08-10 |
| LDH ISOENZYME REAGENT (K781125) | Electrophoresis Corp. of America | 1978-08-10 |
| ECA BUFFER PH 8.8 (K781118) | Electrophoresis Corp. of America | 1978-08-10 |
| CPK ISOENZYME REAGENT (K781124) | Electrophoresis Corp. of America | 1978-08-10 |
| PONCEAU S (K781123) | Electrophoresis Corp. of America | 1978-08-10 |
| ENZYMATIC REAGENT FOR CHOLESTEROL MEAS (K781013) | Coulter Electronics, Inc. | 1978-07-28 |
| LIQUID CHROMATOGRAPH MODEL 850 (K780944) | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| QUANTITATIVE DETERMINATION OF PORPHYRINS (K780455) | Whale Scientific, Inc. | 1978-07-27 |
| LIQUID CHROMATOGRAPH MODEL 860 (K780945) | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| CALCIUM REAGENT SYSTEM NO. 585 (K780983) | Sigma Chemical Co. | 1978-07-27 |
| (AST) OR (ALT) UV DETERM. PHY. PHOS. (K781020) | The Dow Chemical Co. | 1978-07-27 |
| RIA TSH IN HUMAN SERUM OR PLASMA (K781150) | Diagnostic Corp. of America | 1978-07-27 |
| BUN TEST UNI-UV BLOOD UREA NITROGEN TEST (K780943) | Sclavo, Inc. | 1978-07-27 |
| RIA TEST KIT SYS. DAMON KIQUISOL FREE (K781012) | Damon Corp. | 1978-07-27 |
| PRINCETON BIOMEDIX URICASE (UV) (K780859) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-07-27 |
| PREP I AUTOMATED SAMPLE PROCESSOR (K780933) | E.I. Dupont DE Nemours & Co., Inc. | 1978-07-27 |
| IN VITRO NEONATAL T4 (K780854) | Clinical Assays, Inc. | 1978-07-27 |
| ANALYZER, SERUM IRON & TOTAL IRON BINDIN (K781009) | Environmental Sciences Assoc., Inc. | 1978-07-27 |
| HMA URIC ACID TEST (K781004) | Hycel, Inc. | 1978-07-27 |
| ACU-TEST IN-HOME PREGNANCY TEST (K781049) | Williams, the J.B. Co., Inc. | 1978-06-29 |
| CLINICAL ANALYZER SYSTEM (K780903) | Bausch & Lomb, Inc. | 1978-06-28 |
| THERMO SET ELECTRONIC TEM. CONTROLLER (K780888) | Gilford Instrument Laboratories, Inc. | 1978-06-28 |
| DILUTER/DISPENSER (K780882) | Innovative Medical Systems, Inc. | 1978-06-28 |
| ADJUSTABLE DISPENSOR (K780912) | Oxford Laboratories, Inc. | 1978-06-28 |
| AUTOMATED ELECTROPHORESIS SYSTEM (K780901) | Olympus Corp. | 1978-06-28 |
| FISHER SPECTROPHOTOMETER (K780902) | Bausch & Lomb, Inc. | 1978-06-28 |
| URIC ACID REFERENCE SERA (K780447) | Macomb Chemical Co. | 1978-06-22 |
| PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE (K780858) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-06-22 |
| RIA SYSTEM FOR HUMAN F-S HORMONE (K780870) | Calbiochem-Behring Corp. | 1978-06-22 |
| IDI 200 GAMMA COUNTER (K780790) | Iso-Data, Inc. | 1978-06-22 |
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