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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1978-07-27

Clearances · page 124 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K781012 RIA TEST KIT SYS. DAMON KIQUISOL FREE Damon Corp. CEC Class II 1978-07-27
K780944 LIQUID CHROMATOGRAPH MODEL 850 E.I. Dupont DE Nemours & Co., Inc. KZR Class I 1978-07-27
K780859 PRINCETON BIOMEDIX URICASE (UV) Bd Becton Dickinson Vacutainer Systems Preanalytic CDO Class I 1978-07-27
K781049 ACU-TEST IN-HOME PREGNANCY TEST Williams, the J.B. Co., Inc. JHJ Class II 1978-06-29
K780903 CLINICAL ANALYZER SYSTEM Bausch & Lomb, Inc. JJQ Class I 1978-06-28
K780901 AUTOMATED ELECTROPHORESIS SYSTEM Olympus Corp. JQT Class I 1978-06-28
K780882 DILUTER/DISPENSER Innovative Medical Systems, Inc. JQW Class I 1978-06-28
K780888 THERMO SET ELECTRONIC TEM. CONTROLLER Gilford Instrument Laboratories, Inc. JRI Class I 1978-06-28
K780912 ADJUSTABLE DISPENSOR Oxford Laboratories, Inc. JQW Class I 1978-06-28
K780902 FISHER SPECTROPHOTOMETER Bausch & Lomb, Inc. JJQ Class I 1978-06-28
K780870 RIA SYSTEM FOR HUMAN F-S HORMONE Calbiochem-Behring Corp. CGJ Class I 1978-06-22
K780790 IDI 200 GAMMA COUNTER Iso-Data, Inc. JJJ Class I 1978-06-22
K780881 EMIT CLINICAL PROCESSOR - CP 5000 Syva Co. JQP Class I 1978-06-22
K780447 URIC ACID REFERENCE SERA Macomb Chemical Co. JIT Class II 1978-06-22
K780858 PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE Bd Becton Dickinson Vacutainer Systems Preanalytic CFR Class II 1978-06-22
K780393 BIOSTATOR GLUCOSE ANALYZER Miles Laboratories, Inc. CGA Class II 1978-06-19
K780707 T4-RIA KIT Clinical Bioresearch CDX Class II 1978-06-14
K780716 TECHNICON BGII ANALYZER Technicon Instruments Corp. CHL Class II 1978-06-14
K780679 B-HCG-RIA Nuclear Medical Systems, Inc. JHI Class II 1978-06-14
K780785 DILUTOR TRANSPORTER Hyland Therapeutic Div., Travenol Laboratories JQW Class I 1978-06-14
K780659 HDL CHOLESTEROL Macomb Chemical Co. CHH Class I 1978-06-13
K780792 TESTOSTERONE RADIOIMMUNOASSAY KIT 125I The Upjohn Co. CDZ Class I 1978-06-13
K780726 TSH RIA KIT Amersham Corp. JLW Class II 1978-06-13
K780847 NINHYDRIN REAGENT KIT Beckman Instruments, Inc. JMX Class I 1978-06-13
K780799 VITAMIN B12 RADIOASSAY Amersham Corp. CDD Class II 1978-06-13
K780802 ARMTROL AND FERMTROL Biotron , Ltd. JJW Class I 1978-06-13
K780791 SGPT/ALT REAGENT SYSTEM American Monitor Corp. CKA Class I 1978-06-13
K780827 URIC ACID RAPID STAT KIT Pierce Chemical Co. KNK Class I 1978-06-13
K780789 PERALISTIC PUMP MODEL 2000 Innovative Medical Systems, Inc. JQW Class I 1978-06-13
K780801 ISOZYME - ID CPK MARKER Dade, Baxter Travenol Diagnostics, Inc. JJT Class I 1978-06-13
K780725 CENTRIA CORTISOL RIA Union Carbide Corp. CGR Class II 1978-06-06
K780787 TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CDP Class II 1978-06-06
K780554 CLIN. CHEM. CONTROL SERUM-QUANTITATE Beckman Instruments, Inc. JJT Class I 1978-06-06
K780757 KRYORACK/4 Streck Laboratories, Inc. JRR Class I 1978-06-06
K780672 125 I-T4 RIA REAGENT Radioimmunoassay, Inc. CDX Class II 1978-06-06
K780671 125 I-T3 UPTAKE REAGENT Radioimmunoassay, Inc. CEE Class II 1978-06-06
K780783 AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT J.T. Baker Chemical Co. CHH Class I 1978-06-06
K780638 ACCESSORY HDL CHOLESTEROL REAGENT SET The Dow Chemical Co. CHH Class I 1978-05-26
K780412 TOTAL IRON BINDING CAPACITY Diagnostic Corp. of America JQG Class I 1978-05-26
K780543 THERMAJUST CIRCU-TEMP Techhnilab Instruments, Inc. JRQ Class I 1978-05-26
K780825 TRIGLYCERIDE C-37 RAPID STAT KIT Pierce Chemical Co. JGY Class I 1978-05-26
K780545 SR-PLUS DIRECT CHOLESTEROL TEST Stanbio Laboratory CGO Class I 1978-05-26
K780144 DYNEX BLOOD GAS QUALITY CONTROL SYS. Analytical Products, Inc. JJS Class I 1978-05-26
K780341 SCINTILLATION, LIQUID, RACKBETA Lkb Instruments, Inc. JJJ Class I 1978-05-26
K780650 FLAME PHOTOMETER, MODEL 455 Corning Medical & Scientific JJO Class I 1978-05-26
K780826 BILIRUBIN RAPID STAT KIT Pierce Chemical Co. CIG Class II 1978-05-26
K780649 FLAME PHOTOMETER, MODEL 435 Corning Medical & Scientific JJO Class I 1978-05-26
K780534 UREA NITROGEN (ENZYMATIC) Macomb Chemical Co. CDQ Class II 1978-05-19
K780524 ULTRACHEM T-BILI 64971 GILFORD 3500 Harleco CIG Class II 1978-05-19
K780553 COMP. CLIN. CHEM. REF. SERUM-BENCHMARK Beckman Instruments, Inc. JIX Class II 1978-05-19
K780635 REAGENT SET HDL CHOLESTEROL Boehringer Mannheim Corp. CHH Class I 1978-05-19
K780576 125-I LABELED HUMAN LUTEINIZING HORMONE Pcl-Ria, Inc. CEP Class I 1978-05-19
K780552 COMP. CLIN. CHEM. CONTROL SERUM-DECISION Beckman Instruments, Inc. JJY Class I 1978-05-19
K780513 ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 Harleco CIJ Class II 1978-05-19
K780515 ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM Harleco CFR Class II 1978-05-19
K780525 T-3 UPTAKE (SORBENT) KIT Amersham Corp. KHQ Class II 1978-05-19
K780542 ALFATEST Panmed, Inc. LBR Class I 1978-05-19
K780523 ULTRACHEM ENZYMATIC CHOLESTEROL 65025 Harleco CHH Class I 1978-05-19
K780514 ULTRACHEM CREATININE 64972, CENTRIFUCHEM Harleco CGX Class II 1978-05-19
K780634 SINGLE VIAL 10 SGOT-TRIS Boehringer Mannheim Corp. CIT Class II 1978-05-18
K780636 SINGLE VIAL 10 SGPT-TRIS Boehringer Mannheim Corp. CKA Class I 1978-05-18
K780557 FOLATE REAGENT KIT, ARIA-II SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CGN Class II 1978-05-18
K780463 AST(GOT) UNI-UV, SGOT Sclavo, Inc. CIT Class II 1978-05-12
K780522 SPECTROPHOTOMETERS, ATOMIC ABSORPTION Instrumentation Laboratory CO JXR Class I 1978-05-12
K780379 DATA-ZYME TRIGLYCERIDE PROCEDURE Data Medical Associates, Inc. CDT Class I 1978-05-12
K780521 SPECTROPHOTOMETER, ATOMIC ABSORPTION Instrumentation Laboratory CO JXR Class I 1978-05-12
K780462 ALT(GPT) UNI-UV, SGPT Sclavo, Inc. CKA Class I 1978-05-12
K780499 CBR-T3RIA KIT Clinical Bioresearch CDP Class II 1978-05-04
K780507 SERUM GLUTAMIC-PYRUVIC TRANSAMINASE Gamma Enterprises, Inc. CKC Class I 1978-05-03
K780500 CBR-T3 UPTAKE KIT Clinical Bioresearch KHQ Class II 1978-05-03
K780504 CREATINE PHOSPHOKINASE (CPK) Gamma Enterprises, Inc. JHS Class II 1978-05-03
K780482 KOVA TROL III Icl Scientific JJW Class I 1978-05-03
K780505 SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE Gamma Enterprises, Inc. CIT Class II 1978-05-03
K780173 LYPOPROTEIN CHOLESTEROL TEST KIT Environmental Chemical Specialties JHM Class I 1978-05-03
K780506 CARBON DIOXIDE REAGENTS Gamma Enterprises, Inc. KMS Class II 1978-05-03
K780512 AUTO/STAT KIT Pierce Chemical Co. CGA Class II 1978-05-03
K780639 EMIT CENTRIFICHEM THYROXINE ASSAY Syva Co. CDX Class II 1978-05-03
K780508 QUANTITOPE 125I-FOLATE RADIOASSAY KIT Kallestad Laboratories, Inc. CGN Class II 1978-05-03
K780464 LELECTIVE KINETIC SYSTEM-60 Hycel, Inc. JJE Class I 1978-05-03
K780367 RIA SYS. FOR HUMAN LUTEINIZING HORMONE Calbiochem-Behring Corp. CEP Class I 1978-04-28
K780492 GAMMA STIK 125I T3 UPTAKE KIT Alpha Gamma Laboratory CDP Class II 1978-04-28
K780644 RADIOASSAY FOR TOTAL SERUM THYROXINE Nuclear Diagnostics, Inc. CDX Class II 1978-04-28
K780373 STAC SYSTEM Technicon Instruments Corp. CKA Class I 1978-04-28
K780486 STIKSEP-T3 KIT Nuclear Diagnostics, Inc. CEE Class II 1978-04-28
K780401 THYRO-ZYME-T4 ASSAY KIT Coulter Electronics, Inc. CDX Class II 1978-04-24
K780544 DISC-PAK ROTATOR Techhnilab Instruments, Inc. GLE Class I 1978-04-24
K780443 SGOT/AST REAGENT SYSTEM American Monitor Corp. CIT Class II 1978-04-24
K780467 EMIT ANTIEPILEPTIC DRUG CALIBRATORS Syva Co. JIS Class II 1978-04-24
K780351 NORMAL UNASSAYED CONTROL SERA Macomb Chemical Co. JJY Class I 1978-04-24
K780389 HDL REAGENT SET FOR LIPOPROTEINS Worthington Biochemical Corp. CHH Class I 1978-04-19
K780439 PRECIMAT GLYCEROL Boehringer Mannheim Corp. JGW Class I 1978-04-18
K780563 SINGLE VIAL LACTATE Boehringer Mannheim Corp. CFJ Class II 1978-04-18
K780318 MODULAR SCANNING DENSITOMETER SYS. Transidyne General Corp. JQT Class I 1978-04-12
K780347 RIA SYS. FOR HUMAN GROWTH HORMONE Calbiochem-Behring Corp. CFL Class I 1978-04-12
K771614 AUTO. WELL TYPE GAMMA COUNTERS Actus, Inc. JJJ Class I 1978-04-12
K780344 GAMMA COUNTER Lkb Instruments, Inc. JJJ Class I 1978-04-12
K780308 OREIA-T4 Organon, Inc. CDX Class II 1978-04-12
K771612 WELL TYPE GAMMA COUNTER Actus, Inc. JJJ Class I 1978-04-10
K771613 WELL TYPE GAMMA COUNTER Actus, Inc. JJJ Class I 1978-04-10
K780342 SPECTROPHOTOMETERS The Perkin-Elmer Corp. JXR Class I 1978-04-10

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.