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Diagnostic Chemicals , Ltd.

FDA 510(k) & PMA Approved Devices — 66 products

Total Devices66
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K070383 ENZYMATIC CREATININE ASSAY (265 SERIES)JFY2007-06-22 View
510(k) K063208 MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7JGJ2007-01-19 View
510(k) K060139 CRP-ADVANCE ASSAY, MODELS 250-20, 250-25DCK2006-04-28 View
510(k) K060140 CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250JIT2006-04-24 View
510(k) K051757 CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91CJY2005-11-10 View
510(k) K051191 DCL MICROALBUMIN ASSAY, MODEL 252-20DCF2005-07-05 View
510(k) K042330 ACETAMINOPHEN-SL ASSAYLDP2005-01-07 View
510(k) K042329 SALICYLATE-SL ASSAYDKJ2004-12-27 View
510(k) K042362 MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12KHS2004-12-27 View
510(k) K041928 HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50BLBS2004-11-23 View
510(k) K041927 LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40MRR2004-11-23 View
510(k) K041926 HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278JIX2004-11-23 View
510(k) K042243 MICROALBUMIN MULTI-CALIBRATOR SETJIX2004-10-04 View
510(k) K041666 DC-ACETA/SAL CONTROLSDIF2004-08-17 View
510(k) K033921 AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10JIF2004-03-10 View
510(k) K023739 GLUCOSE-SL-C ASSAY, MODEL 257-30CFR2003-01-17 View
510(k) K023330 BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30CIG2002-12-11 View
510(k) K020816 IRON-PC-SL ASSAY MODEL # 151-10, 151-26JIY2002-05-14 View
510(k) K013178 DC-UIBC-CO2-CAL, MODEL SE-153JIX2001-12-18 View
510(k) K003093 ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30CJE2000-11-27 View
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