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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1979-02-22

Clearances · page 122 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790073 ANALYZER, IMPACT 100 Gilford Instrument Laboratories, Inc. JJI Class I 1979-02-22
K782143 RIA KIT, GLUCOSE Serono Laboratories, Inc. JME Class I 1979-02-22
K790045 REAGENT KIT, CHLORIDE/CARBON DIOXIDE J.T. Baker Chemical Co. JFS Class II 1979-02-22
K790072 ANALYZER, IMPACT 200 Gilford Instrument Laboratories, Inc. JJE Class I 1979-02-22
K790044 REAGENT KIT, BAKERS DIAGNOSTIC J.T. Baker Chemical Co. CGX Class II 1979-02-22
K790041 ACCESSORY KIT, CENTRIFICHEM Union Carbide Corp. JQW Class I 1979-02-22
K790065 ALKALINE PHOSPHATASE Macomb Chemical Co. CJE Class II 1979-02-21
K782170 SERACON-LP Bhp Diagnostix, Inc. JJX Class I 1979-02-15
K790015 SERUM, CREATININE PHOSPHOKINASE Fisher Scientific Co., LLC JHS Class II 1979-02-15
K790021 SERUM, INORGANIC PHOSPHOROUS Fisher Scientific Co., LLC CEO Class I 1979-02-15
K790016 SERUM, GLUTAMIC-PYRUVIC Fisher Scientific Co., LLC CKA Class I 1979-02-15
K782130 MINI-DILUTER 2 Dynatech Laboratories, Inc. JQW Class I 1979-02-15
K782175 CARTRIDGE HOLDER, RCM 100 Waters Assoc., Inc. KIE Class I 1979-02-15
K790145 SOLVENT DELIVERY SYSTEM Waters Assoc., Inc. KIE Class I 1979-02-15
K782038 SERACON-C Bhp Diagnostix, Inc. JJY Class I 1979-02-08
K782171 SERACON-HDL Bhp Diagnostix, Inc. JJX Class I 1979-02-08
K782037 SERACON-A Bhp Diagnostix, Inc. JIX Class II 1979-02-08
K781961 CONTROL STRIP FOR VISUAL URINALYSIS Miles Laboratories, Inc. JJW Class I 1979-02-08
K790020 SERUM, LACTIC DEHYDROGENASE Fisher Scientific Co., LLC CFJ Class II 1979-02-08
K790027 SHAKER, MODEL SH-510 Sysmex Corp. JRQ Class I 1979-02-08
K782015 A-GENT CK-MB Abbott Laboratories JHW Class II 1979-02-01
K790018 SERUM, POTASSIUM DETERMINATION OF Fisher Scientific Co., LLC CEM Class II 1979-02-01
K790002 PREGNANCY TEST KIT, DAISY 2 IN HOME Boehringer Mannheim Corp. JHJ Class II 1979-02-01
K782085 EMIT THYROXINE ASSAY Syva Co. KLI Class II 1979-02-01
K781953 RIA KIT, IMMO PHASE Corning Medical & Scientific JLW Class II 1979-02-01
K782159 DIAGNOSTIC KIT, FERRITAB-FE-59 Leeco Diagnostics, Inc. JJA Class I 1979-02-01
K782176 HYCEL LDH-INT TEST Hycel, Inc. CFH Class II 1979-01-26
K782160 TOTAL IRON IN SERUM Fisher Scientific Co., LLC JIY Class I 1979-01-26
K782136 GLUCOSE REAGENT SYSTEM American Monitor Corp. CFR Class II 1979-01-26
K782116 KETOSTEROID TEST, HYCEL-17 Hycel, Inc. CCY Class I 1979-01-26
K782109 RIA KIT, GAMMACOAT Clinical Assays, Inc. CDX Class II 1979-01-26
K782110 RIA KIT, RIANEN CORTISOL New England Nuclear CGR Class II 1979-01-26
K781903 RIA KIT, QUANTITOPE CORTISOL Kallestad Laboratories, Inc. CGR Class II 1979-01-26
K782035 HEMESPEC Helena Laboratories JJQ Class I 1979-01-17
K781945 GLUCOSE OXIDASE REAGENT Fermco Biochemics, Inc. CGA Class II 1979-01-17
K782103 RIA KIT, NEONATAL T4 Serono Laboratories, Inc. CDX Class II 1979-01-17
K782094 HILAR Hi Chem, Inc. CGX Class II 1979-01-17
K782052 PROCESSOR, K750 COMPUTER/DATA Kallestad Laboratories, Inc. JQP Class I 1979-01-17
K781806 REAGENT SYSTEM, INORGANIC PHOSPHORUS Sigma Chemical Co. CEO Class I 1979-01-17
K781909 CALCITONIN 125 Cambridge Nuclear Radiopharmaceutical JKR Class II 1979-01-10
K782099 RIA TEST, NORDICALB HPL Nordiclab Intl. JMF Class II 1979-01-10
K782010 HORMONE KIT, PARATHYROID Nichols Institute Diagnostics CEW Class II 1979-01-10
K781938 RIA KIT, GAMMADAB ESTRIOL Clinical Assays, Inc. CGI Class I 1979-01-10
K781915 DATA MODULE Waters Assoc., Inc. KIE Class I 1979-01-10
K782014 ANALYZER ABA-200 Abbott Laboratories JJE Class I 1979-01-10
K781897 STAT KIT, MICROPROTEIN Pierce Chemical Co. CEK Class II 1979-01-10
K781939 REAGENT KIT, TRIGLYCERIDES Beckman Instruments, Inc. CDT Class I 1979-01-10
K781782 BUN Gilford Diagnostics CDQ Class II 1979-01-10
K781921 BILIRUBIN, DINGLE VALVE DPD Boehringer Mannheim Corp. CIG Class II 1979-01-03
K781784 AST Gilford Diagnostics CIT Class II 1979-01-03
K781850 RIA, QUANTIMUNE E3 Bio-Rad CGI Class I 1979-01-03
K782066 EXETRELUT Mcb Manufacturing Chemists, Inc. KEA Class I 1979-01-03
K781970 CHOLESTEROL REAGENT SUBSTRATE SET Corning Medical & Scientific JHO Class I 1979-01-03
K781996 ACID REAGENT, URIC SINGLE VIAL Calbiochem-Behring Corp. CDO Class I 1979-01-03
K781905 RIA KIT, QUANTITOPE T3 UPTAKE Kallestad Laboratories, Inc. KHQ Class II 1979-01-03
K781968 BLOOD GAS SYSTEM MODEL 168 Corning Medical & Scientific CHL Class II 1979-01-03
K781794 BETA-TEC Wampole Laboratories JHI Class II 1978-12-29
K781728 EXTUBE Analytichem International, Inc. KEA Class I 1978-12-20
K781632 UROTRON Boehringer Mannheim Corp. JJQ Class I 1978-12-20
K781691 CHEMSTRIP CONTROL Boehringer Mannheim Corp. JJW Class I 1978-12-20
K781900 ANALYZER, AUTOMED CENTRIFUGAL Autogenic Systems JJG Class I 1978-12-20
K781899 UREA NITROGEN TEST Wako Intl., Inc. CDL Class II 1978-12-20
K781733 RIA KIT, PREG-STAT Serono Laboratories, Inc. JHI Class II 1978-12-20
K781885 SERUM, BLOOD UREA NITIOGEN Fisher Scientific Co., LLC CDW Class II 1978-12-20
K781893 CONTROL, PROTEIN ELECTROPHORESIS Sigma Chemical Co. JJY Class I 1978-12-20
K781771 DETECTOR, MODEL 79875A, VARIABLE Hewlett-Packard Co. KIE Class I 1978-12-20
K781884 SERUM, CREATININE DETERMINATIONS Fisher Scientific Co., LLC CGX Class II 1978-12-20
K781898 CLEARING SOLUTION #ECA01976 Electrophoresis Corp. of America JQK Class I 1978-12-20
K781853 CHOLESTEROL STANDARDS Bd Becton Dickinson Vacutainer Systems Preanalytic JIS Class II 1978-12-04
K781758 SERACON-SRII Bhp Diagnostix, Inc. JIX Class II 1978-12-04
K781883 DILUTER, LSA 290 PIPETTER Kallestad Laboratories, Inc. JQW Class I 1978-12-04
K781865 IRON BINDING CAPICITY MODEL 0370 Stanbio Laboratory JIY Class I 1978-12-04
K781757 SERACON-SRI Bhp Diagnostix, Inc. JIX Class II 1978-12-04
K781546 DIRECT ESTRIOL RIA KIT Immunalysis Corporation CGI Class I 1978-12-04
K781000 PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS Abbott Laboratories CEO Class I 1978-12-04
K781783 BLOOD SUGAR Gilford Diagnostics LFR Class II 1978-12-04
K781269 ELISA SYSTME Gilford Instrument Laboratories, Inc. JJQ Class I 1978-12-04
K781828 COMPUTER, 3500, GILFORD SYSTEM Syva Co. KLI Class II 1978-12-04
K781769 IRON 59 KIT Ria Products, Inc. JJA Class I 1978-12-04
K781859 REAGENT SYSTEM, NO 46-OV FOR CPK Sigma Chemical Co. CGS Class II 1978-12-04
K781773 ALBUMIN REAGENT Gilford Diagnostics CIX Class II 1978-11-22
K781774 TOTAL PROTEIN Gilford Diagnostics CEK Class II 1978-11-22
K781740 REAGENT, HDL Fisher Scientific Co., LLC CHH Class I 1978-11-22
K781504 125I-ALDOSTERONE RIA DIAG. KIT Abbott Laboratories CJM Class II 1978-11-22
K781765 LDH REAGENT SYSTEM American Monitor Corp. CFJ Class II 1978-11-22
K781775 LDH Gilford Diagnostics CFJ Class II 1978-11-22
K781730 RIA, CORTISOL KIT Radioassay Systems Laboratories, Inc. CGR Class II 1978-11-22
K781702 CALIBRATOR, BOVINE SERUM Bio-Reagents & Diagnostics, Inc. JIX Class II 1978-11-15
K781222 ACCUSCREEN T4 Neometrics, Inc. CDX Class II 1978-11-08
K781662 RIA, T3 UPTAKE SOLID PHASE Bd Becton Dickinson Vacutainer Systems Preanalytic KHQ Class II 1978-11-08
K781722 REAGENT SET, TOTAL PROTEIN Medical Analysis Systems, Inc. CEK Class II 1978-11-03
K781719 CPK REAGENT SET, NAD REDUCTION Medical Analysis Systems, Inc. CGS Class II 1978-11-03
K781718 ALP REAGENT SET, ALKALINE PHOSPHATASE Medical Analysis Systems, Inc. CJE Class II 1978-11-03
K781720 HBDH ENZYME KINETIC REAGENT SET Medical Analysis Systems, Inc. JMK Class I 1978-11-03
K781725 REAGENT SET, U.V. ENZMATIC KINETIC, SGOT Medical Analysis Systems, Inc. CIT Class II 1978-11-03
K781724 NAD REDUCTION METHOD, LACTATE PYRIVATE Medical Analysis Systems, Inc. CFJ Class II 1978-11-03
K781726 REAGENT SET, SGPT SERUM GLUTAMIC Medical Analysis Systems, Inc. CKA Class I 1978-11-03
K781721 REAGENT SET, CHOLESTEROL Medical Analysis Systems, Inc. CHH Class I 1978-11-03
K781723 GLUCOSE HEXOKINASE, AUTO K Medical Analysis Systems, Inc. CFR Class II 1978-11-03
K781685 RIA KIT, LH Amersham Corp. CEP Class I 1978-10-27

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