Diagnostic Chemicals , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ENZYMATIC CREATININE ASSAY (265 SERIES), MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7, CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
66
Total
66
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diagnostic Chemicals , Ltd. Toxicology ✕
14 devices
Cleared
Jan 07, 2005
ACETAMINOPHEN-SL ASSAY
Toxicology
133d
Cleared
Dec 27, 2004
SALICYLATE-SL ASSAY
Toxicology
122d
Cleared
Aug 17, 2004
DC-ACETA/SAL CONTROLS
Toxicology
60d
Cleared
Sep 26, 2000
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
Toxicology
55d
Cleared
Jun 20, 2000
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
Toxicology
60d
Cleared
Jan 18, 2000
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
Toxicology
61d
Cleared
Jun 29, 1998
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
Toxicology
32d
Cleared
May 12, 1998
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
Toxicology
50d
Cleared
Apr 01, 1998
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12
Toxicology
162d
Cleared
Mar 03, 1998
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
Toxicology
57d
Cleared
Mar 02, 1998
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
Toxicology
56d
Cleared
May 24, 1996
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
Toxicology
165d