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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1979-06-27

Clearances · page 121 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790911 RIA OF PROGESTERONE Calbiochem-Behring Corp. JLS Class I 1979-06-27
K790906 AUTOPAK CORTISOL TEST DELIVERY SYSTEM Micromedic Systems CGR Class II 1979-06-27
K790907 AUTOPAK TEST DELIVERY SYSTEM Micromedic Systems CDX Class II 1979-06-27
K790908 RIA, TEST SET CENTRIA T3 Ventrex Laboratories, Inc. CDP Class II 1979-06-27
K790918 ESKLAB REAGENT TABLETS Smithkline Diagnostics, Inc. JHS Class II 1979-06-22
K790917 SPIN CHEM CK-NAC REAGENT Smithkline Diagnostics, Inc. JHS Class II 1979-06-22
K790916 CK-NUC REAGENT Smithkline Diagnostics, Inc. JHS Class II 1979-06-22
K790800 CENTRIA T4 RIA TEST SET Ventrex Laboratories, Inc. CDX Class II 1979-06-15
K790611 OSMOMETER MODEL 3W11 Advanced Instruments, Inc. JJM Class I 1979-06-15
K790773 ENZYMATIC TRIGLYCERIDES-S.V.R. Calbiochem-Behring Corp. CDT Class I 1979-06-15
K790553 CHOLESTEROL KIT, HDL-DS Beckman Instruments, Inc. LBS Class I 1979-06-15
K790653 NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER Nova Corp. CGZ Class II 1979-06-15
K790905 NUCLEAR SAMPLE READER Abbott Laboratories JJJ Class I 1979-06-15
K790786 GLUCOSE (HK) REAGENT Gilford Diagnostics CFR Class II 1979-06-15
K790791 ELECTROPHORESIS REAGENT SET, HDL Gelman Sciences, Inc. LBT Class I 1979-06-15
K790734 PREGNOSTICON PREGNANCY TEST KIT Organon, Inc. JHJ Class II 1979-06-15
K790772 CHEMTAB Boehringer Mannheim Corp. JIM Class II 1979-06-15
K790608 BL BILIRUBINOMETER Advanced Instruments, Inc. CIG Class II 1979-06-15
K790798 FETAL MATURITY TEST PROCEDURE Helena Laboratories JHG Class II 1979-06-05
K790580 RIA KIT, PROSTATIC ACID Monitor Science Corp. JFH Class II 1979-05-25
K790686 EMIT CFA THYROXINE ASSAY Syva Co. KLI Class II 1979-05-25
K790760 REAGENT SYSTEM #350HDL, SIGMA PROCEDURE Sigma Chemical Co. CHH Class I 1979-05-23
K790397 CONCEP-7-B-HCG Leeco Diagnostics, Inc. JHI Class II 1979-05-23
K790524 DATA-ZYME ACIA PHOSPHATASE PROCEDURE Data Medical Associates, Inc. CKE Class II 1979-05-23
K790724 ENZYMATIC DETERMINATION Sigma Chemical Co. CHH Class I 1979-05-23
K790679 ESTRADIOL RIA KIT Serono Laboratories, Inc. CHP Class I 1979-05-23
K790768 WAKO CHOLESTEROL TEST Wako Intl., Inc. CHH Class I 1979-05-23
K790643 CENTRIFICHEM FILTER CALIBRATION SET Union Carbide Corp. JIW Class II 1979-05-23
K790581 CHROMATOGRAPHY TUBES Miles Laboratories, Inc. CDP Class II 1979-05-15
K790421 ROCHE LACTATE ANALYZER 640 Roche Medical Electronics, Inc. KHP Class I 1979-05-15
K790578 GAMMA SMAC REAGENTS Gamma Enterprises, Inc. CIG Class II 1979-05-15
K790771 LD-P REAGENT (LDH P-L REAGENT) Gilford Diagnostics CFJ Class II 1979-05-15
K790662 CENTRIFICHEM INORGANIC PHOSPHORUS Union Carbide Corp. CED Class I 1979-05-15
K790665 NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM Micromedic Systems CDX Class II 1979-05-15
K790817 RIA KIT, QUANTITATION OF PROSTATIC ACID New England Nuclear JFH Class II 1979-05-07
K790556 CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC Calbiochem-Behring Corp. CHH Class I 1979-05-07
K790550 CENTRIA SYSTEM Union Carbide Corp. JJG Class I 1979-05-07
K790317 PAP RIA KIT Yang Laboratories, Inc. JFH Class II 1979-05-07
K790483 COULTER ACCU-ZYME II GOT REAGENT Coulter Electronics, Inc. CIT Class II 1979-05-03
K790549 HEATING BLOCK, WAMPOLE 37 C Armkel, LLC JRG Class I 1979-05-03
K790781 SPECTROPHOTOMETER SYSTEM, MODEL AA-475 Varian Assoc., Inc. JXR Class I 1979-05-03
K790780 ATOMIC ABSORPTION SPECTROPHOTOMETER, Varian Assoc., Inc. JXR Class I 1979-05-03
K790485 AMYLOCHROME STAT SEPARATOR, TEST Hoffmann-La Roche, Inc. JKA Class II 1979-05-03
K790440 PROGESTERONE Serono Laboratories, Inc. JLS Class I 1979-05-03
K790495 THYROXINE RIA KIT Technia Diagnostics , Ltd. CDX Class II 1979-05-03
K790543 THE ABBOTT EXECUTIVE Abbott Laboratories JQP Class I 1979-05-03
K790372 H-D-EL General Diagnostics LBR Class I 1979-05-03
K790461 T-3 UPTAKE (MAA) KIT Amersham Corp. KHQ Class II 1979-05-03
K790474 SZAMYL 6.5 Worthington Diagnostic Systems CIJ Class II 1979-05-01
K790522 COULTER ACCU-ZYME II GPT REAGENT Coulter Electronics, Inc. CKA Class I 1979-05-01
K790343 DATA-ZYME CK CALORIMETRIC/UV PROCEDURE Data Medical Associates, Inc. JHS Class II 1979-05-01
K790477 TY RIA KIT, AUTOMATED ASSAY SYSTEM E. R. Squibb & Sons, Inc. CDX Class II 1979-04-26
K790486 FLOZYME* URIC ACID REAGENT Worthington Diagnostic Systems KNK Class I 1979-04-23
K790422 MULTISKAN (78-503-00) Flow Laboratories, Inc. JJQ Class I 1979-04-20
K790417 T3 UPTAKE KIT E. R. Squibb & Sons, Inc. KHQ Class II 1979-04-20
K790040 P.A.P. TEST KIT, RIA-ZYME Mallinckrodt Critical Care JFH Class II 1979-04-17
K790309 CPK ISOENZYME SUBSTRATE Electrophoresis Corp. JHY Class II 1979-04-04
K790278 ANALYZER, CENTRIFUCHEM SYSTEM 400 Union Carbide Corp. JJG Class I 1979-04-04
K790111 ATOMIZER, FURNACE MODEL HGA-400 The Perkin-Elmer Corp. JXR Class I 1979-04-04
K790376 DUPONT ACA CKMB VERIFIERS E.I. Dupont DE Nemours & Co., Inc. JJX Class I 1979-04-04
K782063 PREGNANCY, SENSIDEX TUBE TEST Ortho Diagnostics, Inc. JHJ Class II 1979-04-04
K790336 UNION CARBIDE CORP. COMPUTER INTERFACE Union Carbide Corp. JQP Class I 1979-04-04
K790329 A-GENT-HDL REAGENT Abbott Laboratories LBR Class I 1979-04-04
K790268 CORTISOL RIA KIT E. R. Squibb & Sons, Inc. CGR Class II 1979-04-04
K782166 SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 Ortho Diagnostics, Inc. JHJ Class II 1979-04-04
K790371 MACOMB LIPID CONTROL Macomb Chemical Co. JJY Class I 1979-04-04
K790248 NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) Boehringer Laboratories CFJ Class II 1979-04-04
K790357 CPK-CS Hoffmann-La Roche, Inc. JHT Class II 1979-04-04
K782077 LANCER ICE CUBE Sherwood Medical Industries JRM Class I 1979-04-03
K790260 NTSH AUTOPAK TEST DELIVERY SYSTEM Micromedic Systems JLW Class II 1979-03-21
K790281 DIAGNOSTIC SET, LIPO-FRAX Analytical Products, Inc. LBS Class I 1979-03-21
K782081 RIA SYSTEM, PARATHYROID HORMONE Iso-Tex Diagnostics CEW Class II 1979-03-21
K790311 LDH ISOENZYME REAGENT Electrophoresis Corp. CFE Class II 1979-03-21
K790267 SENSI-TEX Hoffmann-La Roche, Inc. JHJ Class II 1979-03-21
K790319 ORTHO-TOLUIDINE REAGENT SET Fisher Scientific Co., LLC CGE Class II 1979-03-21
K790129 SERUM PAK, HCG CONTROL Mallinckrodt Critical Care JJX Class I 1979-03-21
K790294 BUFFER, CORNING MOPSO Corning Medical & Scientific JHX Class II 1979-03-21
K790264 DATA-TOPE TRI-RAC RADIOASSAY CONTROL Dade, Baxter Travenol Diagnostics, Inc. JJY Class I 1979-03-21
K790117 AUTOSAMPLER, MODEL AS-40 The Perkin-Elmer Corp. JXR Class I 1979-03-19
K790235 SPECTROPHOTOMETER MODEL 3000 The Perkin-Elmer Corp. KHO Class I 1979-03-15
K790330 CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN Calbiochem-Behring Corp. JJY Class I 1979-03-15
K790236 SPECTROPHOTOMETER MODEL 650-40 The Perkin-Elmer Corp. KHO Class I 1979-03-15
K790138 CHORIC-SHURE Nuclear Medical Laboratories, Inc. JHI Class II 1979-03-12
K790088 ACA CREATINE KINASE ISOENZYMES E.I. Dupont DE Nemours & Co., Inc. JHS Class II 1979-03-12
K790092 URIC ACID, BOUND ENZYME Technicon Instruments Corp. KNK Class I 1979-03-12
K790003 RIA KIT, PROLACTIN Cis Radiopharmaceuticals, Inc. CFT Class I 1979-03-12
K790197 REAGENT KIT, LANCER GLUCOSE Sherwood Medical Industries JJF Class I 1979-03-12
K790103 NEPHELOMETER, MIC-2000 LASER Dynatech Corp. JQX Class I 1979-03-12
K790133 SPINSEP-FE59 Nuclear Diagnostics, Inc. JQG Class I 1979-03-02
K782156 UNITEST CREATINE KINASE Boehringer Mannheim Corp. JLB Class I 1979-03-02
K782032 UNITEST AMYLASE Boehringer Mannheim Corp. CIW Class II 1979-03-02
K782009 RIA KIT, PROGESTERONE The Upjohn Co. JLS Class I 1979-03-02
K782024 RIA KIT, VITAMIN B12 Technia Diagnostics , Ltd. CDD Class II 1979-02-28
K790335 HYCEL M Hycel, Inc. JJF Class I 1979-02-27
K790019 SERUM, URIC ACID DETERMINATION Fisher Scientific Co., LLC CDH Class I 1979-02-26
K782124 IEC CENTRA-7 CENTRIFUGE MODEL 2362 Damon Corp. JQC Class I 1979-02-26
K790008 I ESTRIOL Cambridge Nuclear Corp. CGI Class I 1979-02-26
K782039 SERACON-N Bhp Diagnostix, Inc. JIX Class II 1979-02-26
K790017 SERUM, GLUTAMIC-OXALOACETIC Fisher Scientific Co., LLC CIT Class II 1979-02-26
K790007 I TESTOTERONE Cambridge Nuclear Corp. CDZ Class I 1979-02-26

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