meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1986-09-09

Clearances · page 87 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K863063 CHOLESTEROL-E FAST (TOTAL) J. D. Assoc. CHH Class I 1986-09-09
K863074 TOTAL PROTEINS J. D. Assoc. CEK Class II 1986-09-09
K863076 UREAFAST J. D. Assoc. CDL Class II 1986-09-09
K862640 AMYLASE LTS Electro-Nucleonics Laboratories, Inc. CJA Class II 1986-09-09
K863113 URICMETER J. D. Assoc. KNK Class I 1986-09-09
K863078 CREATININE-E J. D. Assoc. JFY Class II 1986-09-09
K863055 BILIFAST J. D. Assoc. CIG Class II 1986-09-09
K862235 CIBA CORNING MAGIC LITE ANALYZER Ciba Corning Diagnostics Corp. JJE Class I 1986-09-08
K862721 ENZYMATIC BLOOD GLUCOSE U. S. Diagnostics, Inc. CGA Class II 1986-09-03
K863005 EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 Em Diagnostic Systems, Inc. CEK Class II 1986-08-29
K862407 CIBA CORNING MAGIC LITE TSH IMMUNOASSAY Ciba Corning Diagnostics Corp. JLW Class II 1986-08-29
K862819 AVL MODEL 984 ELECTROLYTE ANALYZER Avl Scientific Corp. JGS Class II 1986-08-29
K863094 SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) Em Diagnostic Systems, Inc. CIT Class II 1986-08-29
K860682 GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET Gambro, Inc. CGA Class II 1986-08-29
K862845 EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 Em Diagnostic Systems, Inc. LBS Class I 1986-08-29
K862905 ALP (OPT) REAGENT Sigma Diagnostics, Inc. CJE Class II 1986-08-29
K861414 ELECTROPHORESIS WORK CENTER (EWC) Helena Laboratories JJN Class I 1986-08-26
K861386 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG) Eastman Kodak Company JGJ Class I 1986-08-26
K863196 BUN (RATE) REAGENT Sigma Diagnostics, Inc. CDQ Class II 1986-08-26
K862834 MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) CEO Class I 1986-08-19
K862707 EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 Em Diagnostic Systems, Inc. CHH Class I 1986-08-19
K862306 KING DIAGNOSTICS LDH TEST King Diagnostics, Inc. CFJ Class II 1986-08-19
K862428 STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade JLW Class II 1986-08-19
K862603 DOUBLE ANTIBODY ESTRADIOL RIA KIT Diagnostic Products Corp. CHP Class I 1986-08-19
K863002 EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 Em Diagnostic Systems, Inc. JGJ Class I 1986-08-19
K862818 STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY American Dade JJE Class I 1986-08-19
K862956 ICON READER Hybritech, Inc. JQT Class I 1986-08-19
K860823 ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT Cis-Us, Inc. CFT Class I 1986-08-19
K862359 METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM E.I. Dupont DE Nemours & Co., Inc. CIG Class II 1986-08-19
K862594 SERACON(TM) CAL (PRODUCT NO. DO35) Bhp Diagnostix, Inc. JIX Class II 1986-08-19
K862439 SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA Boots-Celltech Diagnostics, Inc. CGJ Class I 1986-08-19
K862704 EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 Em Diagnostic Systems, Inc. JIS Class II 1986-08-19
K861508 WAKO MICRO TP Wako Chemicals USA, Inc. CEK Class II 1986-08-19
K862525 EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95 Em Diagnostic Systems, Inc. JIT Class II 1986-08-19
K862871 RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL Cambridge Medical Technology CGR Class II 1986-08-19
K862701 SURESPOT Helena Laboratories JQW Class I 1986-08-19
K862833 MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT Diagnostic Chemicals, Ltd. (Usa) CKA Class I 1986-08-19
K862453 EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 Em Diagnostic Systems, Inc. JIS Class II 1986-08-19
K862706 EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 Em Diagnostic Systems, Inc. CDT Class I 1986-08-19
K862108 ENZYMUN-TEST HCG Boehringer Mannheim Corp. DHA Class II 1986-08-19
K861844 GLUCOFACTS DATA MANAGEMENT SYSTEM Miles Laboratories, Inc. JQP Class I 1986-08-12
K862832 MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT Diagnostic Chemicals, Ltd. (Usa) CIT Class II 1986-08-12
K861779 GLUCOFACTS DATA PRINTER Miles Laboratories, Inc. JQP Class I 1986-08-08
K862278 GAS-TRAK United Diagnostics, Inc. JJY Class I 1986-08-04
K860828 FORETEL, COLOR OVULATION TEST Nms Pharmaceuticals, Inc. CEP Class I 1986-08-04
K862542 CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY Supelco, Inc. DII Class I 1986-08-04
K862703 EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 Em Diagnostic Systems, Inc. JIX Class II 1986-08-04
K854329 DIAGEM 300 BG REAGENT STRIPS Seton Products, Inc. CGA Class II 1986-08-04
K855178 DIATRON BLOOD GLUCOSE METER Dextron, Inc. CGA Class II 1986-08-04
K862420 UTAK-STABBS TOXICOLOGY CONTROL Utak Laboratories, Inc. JJY Class I 1986-08-04
K862440 PARAMAX LIPASE REAGENT American Dade CET Class I 1986-08-04
K862587 CHEMTROL(TM) G.B.F. Industries, Inc. JJY Class I 1986-08-04
K862206 TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER Micromedic Systems JJJ Class I 1986-08-04
K862586 CHEMVARION(TM) G.B.F. Industries, Inc. JJY Class I 1986-08-04
K862185 LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL Bio-Rad JJY Class I 1986-08-04
K862370 DART AMYLASE-D.S. REAGENT SYSTEM Coulter Electronics, Inc. CIJ Class II 1986-08-01
K861786 DU PONT DRUG CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIX Class II 1986-07-29
K860538 RIGHT-DAY URINARY LH (EIA) Leeco Diagnostics, Inc. CEP Class I 1986-07-29
K862255 LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) Sterling Diagnostics, Inc. CFJ Class II 1986-07-29
K861792 TWIN GOT-AST IFCC/GPT-ALT IFCC Boehringer Mannheim Corp. CKA Class I 1986-07-29
K862274 ANALYST ANALYTICAL TEST ROTORS E.I. Dupont DE Nemours & Co., Inc. CIC Class II 1986-07-29
K862247 TARGET HCG, ENZYME IMMUNOASSAY REAGENTS V-Tech, Inc. JHI Class II 1986-07-29
K862262 HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS Serono Diagnostics, Inc. JHI Class II 1986-07-29
K861703 LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) Leeco Diagnostics, Inc. JHJ Class II 1986-07-29
K862506 THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR Millipore Corp. KIE Class I 1986-07-29
K862541 LIQUID CHROMATOGRAPHY COLUMNS Supelco, Inc. DPM Class I 1986-07-29
K862300 AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT Amresco, Inc. JGM Class II 1986-07-29
K861733 ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS Kyoto Diagnostics, Inc. JIL Class II 1986-07-25
K862033 TRIGLYCERIDES Pointe Scientific, Inc., CDT Class I 1986-07-22
K861797 ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY Nichols Institute Diagnostics CEW Class II 1986-07-22
K862019 ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT Beckman Instruments, Inc. MSJ Class I 1986-07-18
K862386 ICS APOLIPOPROTEIN B REAGENT TEST KIT Beckman Instruments, Inc. MSJ Class I 1986-07-18
K862507 FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) Sclavo, Inc. CHH Class I 1986-07-16
K860813 MICROMEDIC HTSH MONOCLONAL IRMA KIT Micromedic Systems JLW Class II 1986-07-14
K860309 HEMAFLUOR REAGENT KIT Helena Laboratories KHO Class I 1986-07-14
K862178 ISOPURE LC SYSTEM The Perkin-Elmer Corp. LDM Class I 1986-07-14
K860815 SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) Diagnostic Products Corp. CDD Class II 1986-07-11
K862044 DELFIA (TM) HCG KIT Lkb Instruments, Inc. JHJ Class II 1986-07-11
K861831 REFLOTRON URIC ACID Boehringer Mannheim Corp. KNK Class I 1986-07-11
K862208 KING DIAGNOSTICS URIC ACID TEST King Diagnostics, Inc. KNK Class I 1986-07-08
K861741 TDX REA LACTIC ACID Abbott Laboratories KHP Class I 1986-07-07
K862319 HBDH (OPTIMIZED) REAGENT Sigma Chemical Co. JMK Class I 1986-07-07
K862180 MODIFIED COTROPIN RADIOIMMUNOASSAY KIT Clinetics Corp. CEP Class I 1986-07-07
K861962 VANILMANDELIC ACID (VMA) REAGENT SET Sterling Diagnostics, Inc. CDF Class I 1986-07-07
K861212 DIRECT ACU-SLIDE TEST Cal-Tech Diagnostics, Inc. JHJ Class II 1986-07-07
K861756 V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II Texas Immunology, Inc. JJW Class I 1986-07-07
K860924 RAMP PROGESTURINE PDG ASSAY--48 TEST KIT Monoclonal Antibodies, Inc. JLS Class I 1986-07-02
K862083 HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY Hygeia Sciences JHJ Class II 1986-07-02
K861778 CLINIFACTS 200 DATA MANAGEMENT SYSTEM Miles Laboratories, Inc. JQP Class I 1986-07-02
K860999 GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED Ciba Corning Diagnostics Corp. JJY Class I 1986-07-02
K861303 GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER Miles Laboratories, Inc. CGA Class II 1986-07-02
K861918 V-TREND EIA TSH V-Tech, Inc. JLW Class II 1986-07-02
K855202 GLUCOMETER M BLOOD GULCOSE METER Miles Laboratories, Inc. CGA Class II 1986-07-02
K861674 CHLORIDE PROCEDURE Data Medical Associates, Inc. CHJ Class II 1986-07-01
K861655 CREATININE PROCEDURE Data Medical Associates, Inc. CGX Class II 1986-07-01
K862299 AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS Amresco, Inc. CIG Class II 1986-07-01
K861897 UNISKAN II Flow Laboratories, Inc. JJQ Class I 1986-07-01
K861673 BICARBONATE PROCEDURE Data Medical Associates, Inc. KHS Class II 1986-07-01
K862210 UREA NITROGEN (GLDH) REAGENT SET (UV) Sterling Diagnostics, Inc. CDQ Class II 1986-07-01
K862007 HCG IRMA, CAT. NO. CR-1501 Pacific Biotech, Inc. JHI Class II 1986-07-01

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