FDA 510(k) Applications Submitted by DIAGNOSTIC CHEMICALS, LTD. (USA)

FDA 510(k) Number Submission Date Device Name Applicant
K850788 02/26/1985 GLUTAMYLTRANSFERASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K841664 04/23/1984 ENZYMATIC CO2 DIAGNOSTIC CHEMICAL DIAGNOSTIC CHEMICALS, LTD. (USA)
K841930 05/10/1984 ENZYMATIC ACETAMINOPHEN ASSAY DIAGNOSTIC CHEMICALS, LTD. (USA)
K842155 05/30/1984 SERUM IRON & SERUM IRON BINDING CAPACI DIAGNOSTIC CHEMICALS, LTD. (USA)
K842156 05/30/1984 SERUM IRON & SERUM IRON BINDING CAPACITY DIAGNOSTIC CHEMICALS, LTD. (USA)
K842157 05/30/1984 TRIGLYCERIDE ASSAY KIT-COLORIMETRIC DIAGNOSTIC CHEMICALS, LTD. (USA)
K842159 05/30/1984 CREATININE ASSAY KIT-KINETIC OR ENDPOINT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842160 05/30/1984 CHOLESTEROL ASSSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842242 06/05/1984 UREA ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842243 06/05/1984 ALKALINE PHOSPHATASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842244 06/05/1984 LACTATE DENYDRO GENASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842245 06/05/1984 ASPARTATE AMINOTRANSFERASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842246 06/05/1984 URIC ACID ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842241 06/05/1984 ALANINE AMINOTRANSFERASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K852595 06/19/1985 DC-3 FLUIDS PACK, DC-5 FLUIDS PACK DIAGNOSTIC CHEMICALS, LTD. (USA)
K842506 06/26/1984 GLUCOSE-TRINDER-ADDAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842507 06/26/1984 LACTATE DEHYDROGENASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842508 06/26/1984 CREATINE KINASE ASSAY KIT NAC DIAGNOSTIC CHEMICALS, LTD. (USA)
K842509 06/26/1984 CALCIUM ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K842510 06/26/1984 GLUCOSE ASSAY KIT-HEXOKINASE DIAGNOSTIC CHEMICALS, LTD. (USA)
K842873 07/23/1984 STANDARDS & ACCESSORIES FOR NOVA INSTRU DIAGNOSTIC CHEMICALS, LTD. (USA)
K843030 08/01/1984 INORGANIC PHOSPHORUS ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843031 08/01/1984 MAGNESIUM ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843032 08/01/1984 BILIRUBIN ASSAY KIT - TOTAL DIAGNOSTIC CHEMICALS, LTD. (USA)
K843027 08/01/1984 BILIRUBIN ASSAY KIT DIRECT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843028 08/01/1984 TOTAL PROTEIN ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843029 08/01/1984 HIGH DENSITY LIPOPROTEIN PRECIPITATIN DIAGNOSTIC CHEMICALS, LTD. (USA)
K843057 08/03/1984 UREA ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843104 08/07/1984 ALBUMIN ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843380 08/28/1984 ACID PHOSPHATASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843377 08/28/1984 CREATININE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843378 08/28/1984 ETHYL ALCOHOL ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843379 08/28/1984 VMA ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K843536 09/07/1984 TRIGLYCERIDE ASSAY KIT GPO-CP DIAGNOSTIC CHEMICALS, LTD. (USA)
K852636 06/20/1985 X-AMYLASE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K870336 01/28/1987 SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 DIAGNOSTIC CHEMICALS, LTD. (USA)
K880692 02/22/1988 ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) DIAGNOSTIC CHEMICALS, LTD. (USA)
K881054 03/11/1988 CALCIUM, CATALOGUE NUMBER 122-20 DIAGNOSTIC CHEMICALS, LTD. (USA)
K861094 03/24/1986 BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 DIAGNOSTIC CHEMICALS, LTD. (USA)
K861095 03/24/1986 BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04 DIAGNOSTIC CHEMICALS, LTD. (USA)
K862832 07/25/1986 MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K862833 07/25/1986 MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K862834 07/25/1986 MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K874496 11/02/1987 CALCIUM ASSAY KIT, NUMBER 120-19 DIAGNOSTIC CHEMICALS, LTD. (USA)
K852753 06/28/1985 DC LIQUITROL LEVEL 1 & 2 DIAGNOSTIC CHEMICALS, LTD. (USA)
K853102 07/23/1985 UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN DIAGNOSTIC CHEMICALS, LTD. (USA)
K880866 03/01/1988 CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10 DIAGNOSTIC CHEMICALS, LTD. (USA)
K880867 03/01/1988 AMYLASE 405 CATALOG NUMBER 301-34 DIAGNOSTIC CHEMICALS, LTD. (USA)
K880868 03/01/1988 CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 DIAGNOSTIC CHEMICALS, LTD. (USA)
K901510 03/30/1990 ENZYMATIC THEOPHYLLINE REAGENT, #500-82 DIAGNOSTIC CHEMICALS, LTD. (USA)
K895964 10/11/1989 DCL SYPHILIS-M CATALOG NO. 600-80 DIAGNOSTIC CHEMICALS, LTD. (USA)
K895965 10/11/1989 DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 DIAGNOSTIC CHEMICALS, LTD. (USA)
K874772 11/19/1987 DC-TROL LEVEL 1 OR 2 DIAGNOSTIC CHEMICALS, LTD. (USA)
K882258 05/31/1988 DC-LIQUICAL CATALOGUE #SE-030 DIAGNOSTIC CHEMICALS, LTD. (USA)
K882259 05/31/1988 DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 DIAGNOSTIC CHEMICALS, LTD. (USA)
K860625 02/19/1986 GLUCOSE HK-60 ASSAY KIT CAT. #201-39 DIAGNOSTIC CHEMICALS, LTD. (USA)
K852058 05/09/1985 CHLORIDE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K932555 05/26/1993 DC-LINEATE CAT. NO. SE-091 DIAGNOSTIC CHEMICALS, LTD. (USA)
K932556 05/26/1993 AMMONIA ASSAY CAT. NO. 200-02 DIAGNOSTIC CHEMICALS, LTD. (USA)
K852594 06/19/1985 DC-LIP, CATALOGUE NUMBER SE-020 DIAGNOSTIC CHEMICALS, LTD. (USA)
K912825 06/26/1991 MAGNESIUM ASSAY KIT, CAT.# 100-12 DIAGNOSTIC CHEMICALS, LTD. (USA)
K895873 10/04/1989 CALCIUM, CATALOGUE NUMBER140-20 DIAGNOSTIC CHEMICALS, LTD. (USA)
K904660 10/15/1990 ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 DIAGNOSTIC CHEMICALS, LTD. (USA)
K925877 11/19/1992 DC-UIBC-CAL DIAGNOSTIC CHEMICALS, LTD. (USA)
K875206 12/18/1987 LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 DIAGNOSTIC CHEMICALS, LTD. (USA)
K875207 12/18/1987 ALBUMIN CAT. # 201-03 DIAGNOSTIC CHEMICALS, LTD. (USA)
K875208 12/18/1987 CHLORIDE CAT. # 152-17 DIAGNOSTIC CHEMICALS, LTD. (USA)
K875209 12/18/1987 ACID PHOSPHATASE (KINETIC) CAT. # 320-06 DIAGNOSTIC CHEMICALS, LTD. (USA)
K875210 12/18/1987 ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 DIAGNOSTIC CHEMICALS, LTD. (USA)
K875211 12/18/1987 GLUCOSE (TRINDER) CAT. # 220-32 DIAGNOSTIC CHEMICALS, LTD. (USA)
K974874 12/29/1997 BILIRUBIN-SL (TOTAL) ASSAY DIAGNOSTIC CHEMICALS, LTD. (USA)
K842158 05/30/1984 SALICYLATE ASSAY KIT DIAGNOSTIC CHEMICALS, LTD. (USA)
K932766 06/08/1993 HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) DIAGNOSTIC CHEMICALS, LTD. (USA)
K022538 08/01/2002 IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 DIAGNOSTIC CHEMICALS, LTD. (USA)
K874284 10/14/1987 SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM DIAGNOSTIC CHEMICALS, LTD. (USA)
K885097 12/09/1988 ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 DIAGNOSTIC CHEMICALS, LTD. (USA)
K883148 07/26/1988 IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 DIAGNOSTIC CHEMICALS, LTD. (USA)


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact