Diagnostic Chemicals , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
66
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K070383ENZYMATIC CREATININE ASSAY (265 SERIES)June 22, 2007
K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7January 19, 2007
K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25April 28, 2006
K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250April 24, 2006
K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91November 10, 2005
K051191DCL MICROALBUMIN ASSAY, MODEL 252-20July 5, 2005
K042330ACETAMINOPHEN-SL ASSAYJanuary 7, 2005
K042362MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12December 27, 2004
K042329SALICYLATE-SL ASSAYDecember 27, 2004
K041928HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50BNovember 23, 2004
K041926HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278November 23, 2004
K041927LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40November 23, 2004
K042243MICROALBUMIN MULTI-CALIBRATOR SETOctober 4, 2004
K041666DC-ACETA/SAL CONTROLSAugust 17, 2004
K033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10March 10, 2004
K023739GLUCOSE-SL-C ASSAY, MODEL 257-30January 17, 2003
K023330BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30December 11, 2002
K020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26May 14, 2002
K013178DC-UIBC-CO2-CAL, MODEL SE-153December 18, 2001
K003093ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30November 27, 2000