meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1982-04-16

Clearances · page 109 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K820880 SERALYZER CK REAGENT STRIPS Miles Laboratories, Inc. CGS Class II 1982-04-16
K820879 ENZYME-TEST TBC T4 UPTAKE Icl Scientific KHQ Class II 1982-04-16
K820886 THYROXINE T4 KIT Pcl-Ria, Inc. CDX Class II 1982-04-16
K820760 LH RADIOIMMUNOASSAY TEST SYSTEM Monobind CEP Class I 1982-04-16
K820832 PHOSPHORUS IL American Monitor Corp. CED Class I 1982-04-15
K820763 ENZYM-LINKED T3 Icl Scientific CDP Class II 1982-04-15
K820744 IL MODEL 1301, PH BLOOD GAS SYSTEM Instrumentation Laboratory CO CHL Class II 1982-04-15
K820754 AMERLEX ESH KIT Amersham Corp. CGJ Class I 1982-04-15
K820724 FLUOROGEN PAP FIA Biogenex Laboratories JFH Class II 1982-04-14
K820741 MR1 LUTROPIN RIA KIT Microanalytic Research, Inc. CEP Class I 1982-04-14
K820768 COLORIMETRIC LDH REAGENT SET Biorent Diagnostic, Inc. CFH Class II 1982-04-14
K820812 CREATINE KINASE-MB KIT Calbiochem-Behring Corp. JHY Class II 1982-04-12
K820753 AMERLEX LH RIA KIT (CODE IM2081) Amersham Corp. CEP Class I 1982-04-09
K820750 ENZYMUNE-TEST T4 Icl Scientific KLI Class II 1982-04-06
K820748 POLI-MAK MODEL F-4 (FINAL Pm America, Inc. JJF Class I 1982-04-06
K820740 MR1 FOLLITROPIN RIA KIT Microanalytic Research, Inc. CGJ Class I 1982-04-06
K820728 QUANTIMUNE ESTRIOL RIA Bio-Rad CGI Class I 1982-04-06
K820700 EXTERNAL STANDARDS-SODIUMNPOTASSIUM Shaban Mfg. Co. JIX Class II 1982-04-01
K811927 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY Corning Medical & Scientific LIG Class II 1982-04-01
K820675 BILIRUBIN(TOTAL) DETERMINATION CTMS The Dow Chemical Co. CIG Class II 1982-04-01
K820717 MONOJECT CORVAC STAT VAC TUBE W/THROM Sherwood Medical Co. JKA Class II 1982-04-01
K820705 GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL United Diagnostics, Inc. JJS Class I 1982-04-01
K820686 LIQUISOL PROGESTERONE RADIOIMMUNO Damon Corp. JLS Class I 1982-04-01
K820644 RAICHEM TM CREATINE KINASE REAGENT Reagents Applications, Inc. CGS Class II 1982-04-01
K820722 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE Eastman Kodak Company JHS Class II 1982-04-01
K820687 DUPONT AUTOMATIC CLINICAL ANALYZER E.I. Dupont DE Nemours & Co., Inc. JJE Class I 1982-04-01
K820614 ROCHE B-HCG STANDARDS Hoffmann-La Roche, Inc. JHI Class II 1982-04-01
K820631 CORNING 480 FLAME PHOTOMETER Corning Medical & Scientific JJO Class I 1982-04-01
K820613 ROCHE B-HCG RIA Hoffmann-La Roche, Inc. JHI Class II 1982-04-01
K820721 COMPUTERIZED INTERPRETATION OF ARTERIAL Philip R. Corsello, M.D. JQP Class I 1982-04-01
K820714 DOW BILIRUBIN(DIRECT) DETERMINATION The Dow Chemical Co. CIG Class II 1982-04-01
K820701 NOVA I FLUIDS PACK Shaban Mfg. Co. JIX Class II 1982-04-01
K820698 SYVA ADVANCE STANDARDIZATION KIT 01 Syva Co. JIS Class II 1982-04-01
K820723 KODAK EKTACHEM CLINICAL CHEM. NH3 Eastman Kodak Company JID Class I 1982-04-01
K820597 158 BLOOD GAS ANALYZER Corning Medical & Scientific CHL Class II 1982-03-26
K820358 FOLLICLE STIMULATING HORMONE KIT Pcl-Ria, Inc. CGJ Class I 1982-03-26
K820616 ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY E. R. Squibb & Sons, Inc. CIB Class II 1982-03-26
K813572 CENTRIA PROLACTIN TEST SET Ventrex Laboratories, Inc. CFT Class I 1982-03-26
K820629 CORNING 902 SODIUM POTASSIUM ANALYZER Corning Medical & Scientific CFM Class I 1982-03-25
K820319 FETAL-TEK CONTROL MATURE Helena Laboratories JJS Class I 1982-03-25
K820632 COLORIMETRIC URIC ACID REAGENT SET Biorent Diagnostic, Inc. KNK Class I 1982-03-25
K820357 LUTEINIZING HORMONE KIT Pcl-Ria, Inc. CEP Class I 1982-03-25
K813563 PHADEZYM ANALYZER Pharmacia, Inc. JJQ Class I 1982-03-22
K820534 COAT-A-COUNT PROGESTERONE KIA KIT Diagnostic Products Corp. JLS Class I 1982-03-16
K820376 MICROMEDIC SYSTEMS ISOFLEX Micromedic Systems JJJ Class I 1982-03-16
K820455 CENTRIFREE MICROPARTITION SYSTEM Amicon, Inc. JRL Class I 1982-03-15
K820523 CHORIO-QUANT Nuclear Medical Laboratories, Inc. JHI Class II 1982-03-15
K820525 RAICHEM GPT (ALT) REAGENT Reagents Applications, Inc. CKA Class I 1982-03-15
K820465 CHEMSTRIP UG Biodynamics Corp. CGA Class II 1982-03-11
K820500 TOTAL LIPID REAGENT SET Anco Medical Reagents & Assoc. CFD Class I 1982-03-11
K820415 4150 ALPHA AMINO ACID ANALYZER Lkb Instruments, Inc. JJF Class I 1982-03-11
K820466 SGOT REAGENT SET Anco Medical Reagents & Assoc. CIQ Class II 1982-03-11
K820228 MIN-MOLECULE PTH BY RADIOIMMUNOASSAY Immuno Nuclear Corp. CEW Class II 1982-03-11
K820473 ENZYMATIC CHOLESTEROL REAGENT SYSTEM American Monitor Corp. CHH Class I 1982-03-11
K820427 IL 8060 DATA MANAGEMENT SYSTEM Instrumentation Laboratory CO JQP Class I 1982-03-11
K820321 IMMOPHASE B HCG RADIOIMMUNOASSAY Corning Medical & Scientific JHI Class II 1982-03-11
K820395 LIQUIZYME NA+/K+ REAGENT SET American Research Products Co. JGS Class II 1982-03-11
K820271 ABBOTT LABORATORIES B-HCG EIA Abbott Laboratories JHI Class II 1982-03-11
K820418 K.D. COLORIMETRIC BLOOD UREA N2 TEST King Diagnostics, Inc. JGZ Class II 1982-03-11
K820491 SGPT REAGENT SET Anco Medical Reagents & Assoc. CKD Class I 1982-03-11
K820394 TECHNICON RA-1000 SYSTEM ADD. ANALYT Technicon Instruments Corp. CKA Class I 1982-03-08
K820411 LIQUIZYME CHLORIDE REAGENT American Research Products Co. JFS Class II 1982-03-08
K820378 LD-L TRIS SYSTEM PACK TEST Boehringer Mannheim Corp. CFJ Class II 1982-03-08
K820388 LIQUIZYME CO2REAGENT SET American Research Products Co. JFL Class II 1982-03-08
K813183 NO-BOIL VITABIN B12 5760 FOLATE 125I Corning Medical & Scientific CDD Class II 1982-03-05
K820340 T3 UPTAKE-SQUIBB DIAGNOSTIC KIT E. R. Squibb & Sons, Inc. KHQ Class II 1982-03-04
K820360 AALTO LDH ISOENZYME CONTROL SERUM Aalto Scientific, Ltd. JJT Class I 1982-03-04
K820329 ESTRADIOL KIT BY RIA Immuchem Corp. CHP Class I 1982-03-04
K820341 CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT E. R. Squibb & Sons, Inc. CGR Class II 1982-03-04
K820320 MODEL 3030 ATOMIC ABSORPTION SPECTRO- The Perkin-Elmer Corp. JXR Class I 1982-03-01
K820091 AIRMED SMOKE EVACUATION & FILTER James L. Geraci & Associates, Inc. CIE Class II 1982-02-24
K820224 EMIT FREELEVEL SYSTEM I Syva Co. JRL Class I 1982-02-23
K820283 SIGMA 2000 GAS CHROMATOGRAPH The Perkin-Elmer Corp. KZQ Class I 1982-02-23
K820270 RAICHEM GOT (AST) REAGENT Reagents Applications, Inc. CIT Class II 1982-02-18
K820255 BI-LEVEL ASSAYED URINE METAL CONTROL Ortho Diagnostic Systems, Inc. JJY Class I 1982-02-18
K820273 4050/4051 ULTRASPEC Lkb Instruments, Inc. JJQ Class I 1982-02-18
K820263 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES Eastman Kodak Company CHH Class I 1982-02-18
K820025 TRACE ANALYTICAL REDUCTION GAS ANALYZ Trace Analytical KZQ Class I 1982-02-15
K820241 WAKO CALCIUM C TEST Wako Chemicals USA, Inc. CIC Class II 1982-02-12
K820233 ULTRAZYME PLUS GAMMA GT(65055-65056) Harleco JQB Class I 1982-02-12
K820235 TPTZ CHLORIDE American Monitor Corp. CHJ Class II 1982-02-12
K820217 LKB-WALLACE 1251 LUMINOMETER Lkb Instruments, Inc. JJQ Class I 1982-02-12
K820137 IMMU-COUNT Kemble Instruments, Inc. JJJ Class I 1982-02-05
K820118 ELECTROLYTE ANALYZER ACCESSORY Boehringer Mannheim Corp. JJE Class I 1982-02-04
K820048 FSH RADIOIMMUNOASSAY TEST SYSTEM Monobind CGJ Class I 1982-02-04
K812837 ALKALINE PHOSPHATASE REAGENT SET Anco Medical Reagents & Assoc. CJL Class II 1982-01-29
K813560 LIQUIZYME CREATININE REAGENT SET Amresco, Inc. CGX Class II 1982-01-29
K820090 ASTRA-T CALCIUM REAGENT Hi Chem, Inc. CIC Class II 1982-01-28
K820074 CORTISOL (RIA) KIT Immuno Assay Corp. CGR Class II 1982-01-28
K820103 PATHWAY PH BLOOD GAS CONTROL Beckman Instruments, Inc. JJS Class I 1982-01-28
K820071 MODEL 5790 GAS CHROMATOGRAPH Hewlett-Packard Co. KZQ Class I 1982-01-28
K820089 TSH (RIA) KIT Immuno Assay Corp. JLW Class II 1982-01-28
K820075 SERALYZER CREATININE REAGENT STRIPS Miles Laboratories, Inc. CGX Class II 1982-01-26
K812750 IL 703, STAT SEPARATOR Instrumentation Laboratory CO JRL Class I 1982-01-26
K813127 SODIUM & POTASSIUM PRODUCTS Alko Diagnostic Corp. JIX Class II 1982-01-22
K813645 MICROMEDIC HTSH RIA KIT Micromedic Systems JLW Class II 1982-01-22
K813608 POTASSIUM REAGENT SET Diagnostic Specialties CEJ Class II 1982-01-22
K820039 LEECO PRL-QUANT DIAGNOSTIC TEST KIT Leeco Diagnostics, Inc. CFT Class I 1982-01-22
K812925 ABBOTT PAP-EIA Abbott Laboratories JFH Class II 1982-01-19
K812768 COAT-A-COUNT FREE & TOTAL ESTRIOL KIT Diagnostic Products Corp. CGI Class I 1982-01-18

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