FDA 510(k) Applications Submitted by KAREN CALLBECK, R.T.B.SC.

FDA 510(k) Number Submission Date Device Name Applicant
K980032 01/05/1998 SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 DIAGNOSTIC CHEMICALS LTD.
K980031 01/05/1998 ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 DIAGNOSTIC CHEMICALS LTD.
K000055 01/07/2000 CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 DIAGNOSTIC CHEMICALS LTD.
K960088 01/11/1996 TRUE TRIGLYCERIDE DIAGNOSTIC CHEMICALS LTD.
K980316 01/27/1998 ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 DIAGNOSTIC CHEMICALS LTD.
K980772 02/20/1998 HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 DIAGNOSTIC CHEMICALS LTD.
K980770 02/20/1998 HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 DIAGNOSTIC CHEMICALS LTD.
K990754 03/08/1999 CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 DIAGNOSTIC CHEMICALS LTD.
K961281 04/03/1996 TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 DIAGNOSTIC CHEMICALS LTD.
K961282 04/03/1996 GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 DIAGNOSTIC CHEMICALS LTD.
K001285 04/21/2000 AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 DIAGNOSTIC CHEMICALS LTD.
K001286 04/21/2000 ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 DIAGNOSTIC CHEMICALS LTD.
K961586 04/24/1996 URIC ACID-SL ASSAY CATALOGUE NO. 237-60 DIAGNOSTIC CHEMICALS LTD.
K961587 04/24/1996 IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 DIAGNOSTIC CHEMICALS LTD.
K981609 05/05/1998 BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 DIAGNOSTIC CHEMICALS LTD.
K981872 05/28/1998 SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 DIAGNOSTIC CHEMICALS LTD.
K972337 06/23/1997 DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA DIAGNOSTIC CHEMICALS LTD.
K002354 08/02/2000 CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 DIAGNOSTIC CHEMICALS LTD.
K973108 08/19/1997 TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 DIAGNOSTIC CHEMICALS LTD.
K002694 08/29/2000 UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 DIAGNOSTIC CHEMICALS LTD.
K983019 08/31/1998 CARBON DIOXIDE-SL ASSAY, CAT # 253-01 DIAGNOSTIC CHEMICALS LTD.
K993178 09/23/1999 UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 DIAGNOSTIC CHEMICALS LTD.
K003093 10/03/2000 ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 DIAGNOSTIC CHEMICALS LTD.
K973933 10/15/1997 SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 DIAGNOSTIC CHEMICALS LTD.
K973931 10/15/1997 UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 DIAGNOSTIC CHEMICALS LTD.
K974001 10/21/1997 ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 DIAGNOSTIC CHEMICALS LTD.
K974002 10/21/1997 ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 DIAGNOSTIC CHEMICALS LTD.
K974003 10/21/1997 ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 DIAGNOSTIC CHEMICALS LTD.
K973999 10/21/1997 CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 DIAGNOSTIC CHEMICALS LTD.
K974000 10/21/1997 Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 DIAGNOSTIC CHEMICALS LTD.
K974053 10/27/1997 AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 DIAGNOSTIC CHEMICALS LTD.
K993920 11/18/1999 ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 DIAGNOSTIC CHEMICALS LTD.
K994035 11/29/1999 IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 DIAGNOSTIC CHEMICALS LTD.
K955496 12/01/1995 URIC ACID CATALOGE# 220-93/94/97 DIAGNOSTIC CHEMICALS LTD.
K955498 12/01/1995 CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 DIAGNOSTIC CHEMICALS LTD.
K955633 12/11/1995 ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 DIAGNOSTIC CHEMICALS LTD.
K955880 12/28/1995 DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 DIAGNOSTIC CHEMICALS LTD.
K974858 12/29/1997 PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 DIAGNOSTIC CHEMICALS LTD.
K974859 12/29/1997 LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 DIAGNOSTIC CHEMICALS LTD.
K974874 12/29/1997 BILIRUBIN-SL (TOTAL) ASSAY DIAGNOSTIC CHEMICALS, LTD. (USA)
K981059 03/23/1998 ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. DIAGNOSTIC CHEMICALS LTD.
K963116 08/12/1996 UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY DIAGNOSTIC CHEMICALS LTD.


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