meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1977-12-20

Clearances · page 126 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K771609 PEDIATRIC THYROXINE TEST SYS. T4 Corning Medical & Scientific CDX Class II 1977-12-20
K772176 CYSTIC FIBROSIS TESTING INSTRUMENT Laboratory Equipment Design Co. JJN Class I 1977-12-20
K771909 DUAL WAVELENGTH PHOTOMETER, 1177 Abbott Laboratories JJQ Class I 1977-12-20
K772155 ULTRACHEM TOTAL PROTEIN, #64974 Harleco CEK Class II 1977-12-06
K771662 AUTOMATIC ANALYZER Lachat Chemicals, Inc. JJC Class I 1977-12-06
K771905 GLYCEROL SUBSTRATE Simmler & Son, Inc. CDT Class I 1977-12-06
K772172 DYNAZYME TM II CARDIAK-MB J.T. Baker Chemical Co. JHW Class II 1977-12-06
K771904 GLYCEROL KINASE Simmler & Son, Inc. CDT Class I 1977-12-06
K772088 AMES T-3 UPTAKE STRIP TEST Miles Laboratories, Inc. KHQ Class II 1977-12-06
K771906 PHOSPHATE Simmler & Son, Inc. CDT Class I 1977-12-06
K772109 IN VITRO HUMAN TSH RIA TEST Clinical Assays, Inc. JLW Class II 1977-12-06
K772106 PH CALIBRATION BUFFERS General Diagnostics JIT Class II 1977-12-06
K772157 CREATININE, 64972 Harleco CGX Class II 1977-12-06
K772156 ULTRACHEM PHOSPHORUS, 64973 Harleco CEO Class I 1977-12-06
K771903 LIPASE Simmler & Son, Inc. CDT Class I 1977-12-06
K771874 J-VAC VACUUM TUBE Jelco Laboratories GIM Class II 1977-12-02
K772151 URINARY VMA - SCREEN TEST KIT Eppendorf-Brinkmann, Inc. CDF Class I 1977-11-30
K772107 CREATININE URINE APPLI.-#32308 Harleco CGX Class II 1977-11-28
K771807 SPECTROPHOTOMETER ANALYSIS SYS. Varian Assoc., Inc. JJQ Class I 1977-11-28
K772165 SPECTROPHOTOMETER - SERIES AA-575 Varian Assoc., Inc. JXR Class I 1977-11-28
K772082 ENZAC URIC ACID 100-TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CDH Class I 1977-11-28
K772043 ALPHA/CHOL Standard Scientific, Inc. CGO Class I 1977-11-28
K772086 QUANTROLS HCG Organon, Inc. JHI Class II 1977-11-23
K772039 BETA-HCG RIA Monitor Science Corp. JHI Class II 1977-11-23
K771836 LACTATE DEHYDROGENASE Gamma Enterprises, Inc. CFJ Class II 1977-11-22
K772096 IN VITRO DIAGNOSTIC REAGENT Pcl-Ria, Inc. CDX Class II 1977-11-22
K771102 UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS The Dow Chemical Co. LFR Class II 1977-11-22
K771832 CHLORIDE Gamma Enterprises, Inc. JFS Class II 1977-11-22
K772122 T3 RIA KIT Antibodies, Inc. CDP Class II 1977-11-17
K772033 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* Harleco JMK Class I 1977-11-17
K771979 CENTRIA INSULIN RIA Union Carbide Corp. CFP Class I 1977-11-17
K772108 IN VITRO T3 RIA TEST Clinical Assays, Inc. CDP Class II 1977-11-17
K772032 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP Harleco CJE Class II 1977-11-17
K772035 GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL Harleco JFJ Class II 1977-11-17
K772029 GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT Harleco CIT Class II 1977-11-15
K772028 GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH Harleco CFJ Class II 1977-11-15
K772064 THYRODOT-4 ANTISERA LYOPHOLIZED Medcom Diagnostics, Inc. CDX Class II 1977-11-14
K772030 GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT Harleco CKA Class I 1977-11-14
K771927 IRON SET, ITEM NO. 65008 Harleco JMO Class I 1977-11-14
K771928 CALCIUM SET, ITEM NO. 65004 Harleco CJY Class II 1977-11-14
K771923 FASTCHEM BUN Boehringer Mannheim Corp. CDQ Class II 1977-11-11
K771926 TOTAL PROTEIN SET, ITEM NO. 64010 Harleco CEK Class II 1977-11-11
K772025 URIC ACID STD. FOR QUANT. URIC ACID Worthington Biochemical Corp. JIS Class II 1977-11-11
K772022 SPECTROPHOTOMETER CARY 219 Varian Assoc., Inc. JJQ Class I 1977-11-11
K771821 STAC SYSTEM Technicon Instruments Corp. JJF Class I 1977-11-07
K771849 CPK COLOR TEST KIT Mallinckrodt Critical Care CGS Class II 1977-11-03
K771720 AMIDO BLACK CONCENTRATE Sigma Chemical Co. CEF Class I 1977-11-03
K771939 STAC SYSTEM-ADDI. ANALYTES Technicon Instruments Corp. JJF Class I 1977-11-03
K771856 DIR. QUANT. COLOR. DETERM. SERUM CREAT. Stanbio Laboratory CGX Class II 1977-11-03
K771838 SERUM IRON Gamma Enterprises, Inc. JIY Class I 1977-11-03
K771152 DYNAZYME II GPT 340 J.T. Baker Chemical Co. CKA Class I 1977-11-03
K771153 DYNA ZYME II GOT 340 J.T. Baker Chemical Co. CIT Class II 1977-11-03
K771834 CREATININE Gamma Enterprises, Inc. CGX Class II 1977-11-03
K772014 AMES T-4 STRIP TEST Miles Laboratories, Inc. CDX Class II 1977-11-02
K771829 ALKALINE PHOSPHATASE Gamma Enterprises, Inc. CJE Class II 1977-11-02
K771793 DHEA TEST SET Wien Laboratories, Inc. CIY Class I 1977-11-02
K771835 INORGANIC PHOSPHORUS Gamma Enterprises, Inc. CEO Class I 1977-11-02
K771837 POTASSIUM Gamma Enterprises, Inc. CEM Class II 1977-11-02
K771839 SODIUM Gamma Enterprises, Inc. JGS Class II 1977-11-02
K771985 FILTER SAMPLER BLOOD SERUM FILTER Clasrock GIM Class II 1977-11-02
K771848 PHOSPHORUS TEST KIT Mallinckrodt Critical Care CEO Class I 1977-10-28
K771798 ACA BILIRUBIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JJX Class I 1977-10-28
K771828 ALBUMIN Gamma Enterprises, Inc. CIX Class II 1977-10-25
K771755 9-WAY URINE TEST WITH ASCORBIC Miles Laboratories, Inc. JIL Class II 1977-10-25
K771731 CHOLAR PRODU&T #17010 Hi Chem, Inc. CHH Class I 1977-10-25
K771797 ACA TRIGLYCERIDE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1977-10-25
K771637 SPECTROPHOTOMETER ANALYSIS SYSTEM Varian Assoc., Inc. JJQ Class I 1977-10-25
K771804 ACA AMMONIA CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1977-10-25
K771803 ACA PHOSPHORUS CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1977-10-25
K771800 ACA GLUTAMYL TRANSFERASE E.I. Dupont DE Nemours & Co., Inc. JJT Class I 1977-10-25
K771802 ACA IRON CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1977-10-25
K771801 ACA CARBON DIOXIDE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1977-10-25
K771842 URIC ACID Gamma Enterprises, Inc. CDH Class I 1977-10-25
K771496 CHEMCODE/CHEMTEK SYSTEM Boehringer Mannheim Corp. JJQ Class I 1977-10-25
K771830 BLOOD UREA NITROGEN BUN Gamma Enterprises, Inc. CDW Class II 1977-10-25
K771813 CENTRIFICHEM SYS 400 ANALYZER Clinical Diagnostics, Inc. JJG Class I 1977-10-25
K771507 MULTISTAT III BICARBONATE TEST Instrumentation Laboratory CO KHS Class II 1977-10-25
K771831 CALCIUM Gamma Enterprises, Inc. CIC Class II 1977-10-25
K771767 SERALUTE TSH (RIA) Miles Laboratories, Inc. JLW Class II 1977-10-25
K771841 TOTAL PROTEIN Gamma Enterprises, Inc. CEK Class II 1977-10-25
K771729 17-HYDROXYPROGESTERONE TEST SET Wien Laboratories, Inc. JLX Class I 1977-10-21
K771916 PROCEDURE NO. 555 Sigma Chemical Co. CGX Class II 1977-10-19
K771822 BG II ANALYZER Technicon Instruments Corp. CHL Class II 1977-10-19
K771740 CARDIOZYME CK-CONTROL LEVEL 1 Dade, Baxter Travenol Diagnostics, Inc. JJT Class I 1977-10-19
K771840 TOTAL BILIRUBIN Gamma Enterprises, Inc. CIG Class II 1977-10-19
K771820 ENZYMATIC CHOLESTEROL Macomb Chemical Co. CHH Class I 1977-10-19
K771756 FOLLICLE-STIMULATING HORMONE Nichols Institute Diagnostics CGJ Class I 1977-10-18
K771592 STAT/LYTE ANALYZER Technicon Instruments Corp. JFL Class II 1977-10-18
K771337 I.L. MODEL 643 FLAME PHOTOMETER Instrumentation Laboratory CO JJO Class I 1977-10-18
K771713 TEK-CHEK-2 Miles Laboratories, Inc. JJW Class I 1977-10-18
K771322 ELECTROPHORESIS POWER SUPPLY TESTER Corning Medical & Scientific JJN Class I 1977-10-18
K771378 NEO TSH-RIA KIT Nuclear Medical Systems, Inc. JLW Class II 1977-10-18
K771754 GLUCOSE REAGENT FOR GLUC. ANALYZER Harleco CGA Class II 1977-10-18
K771833 CHOLESTEROL Gamma Enterprises, Inc. CGO Class I 1977-10-18
K771234 TSH RIA REAGENT SET G.D. Searle and Co. JLW Class II 1977-10-18
K771695 ALKALINE PHOSPHATASE TEST Sclavo, Inc. CJE Class II 1977-10-18
K771783 PTH RIA Nichols Institute Diagnostics CEW Class II 1977-10-14
K771773 CLINICARD CREATININE CHEMISTRY Harleco CGX Class II 1977-10-14
K771657 EMIT THYROXINE CONTROL Syva Co. JJX Class I 1977-10-13
K771245 MODEL 2/2 ANALYZER Eastman Kodak Company JJE Class I 1977-10-07

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