Medical Device Manufacturer · CA , Charlottetown, P.E.I.

Diagnostic Chemicals , Ltd. - FDA 510(k) Cleared Devices

66 submissions · 66 cleared · Since 1994

66

Total

66

Cleared

0

Denied

66 devices

51-66 of 66

Cleared Aug 27, 1996

DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05

Chemistry · 243d

Cleared Aug 27, 1996

IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25

Chemistry · 125d

Cleared Aug 20, 1996

UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY

Chemistry · 8d

Cleared Aug 16, 1996

TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60

Chemistry · 135d

Cleared Jul 23, 1996

URIC ACID-SL ASSAY CATALOGUE NO. 237-60

Chemistry · 90d

Cleared Jun 21, 1996

GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60

Chemistry · 79d

Cleared May 24, 1996

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03

Toxicology · 165d

Cleared Apr 01, 1996

TRUE TRIGLYCERIDE

Chemistry · 81d

Cleared Feb 23, 1996

URIC ACID CATALOGE# 220-93/94/97

Chemistry · 84d

Cleared Jan 24, 1996

CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05

Toxicology · 54d

Cleared Sep 06, 1995

ACETAMINOPHEN ASSAY

Toxicology · 72d

Cleared Jun 09, 1995

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05

Chemistry · 193d

Cleared Feb 08, 1995

CATALOGUE NUMBER 321-07/15/50

Chemistry · 104d

Cleared Aug 24, 1994

CK-MB ASSAY, CATALOGUE NUMBER 317-10

Chemistry · 72d

Cleared Mar 11, 1994

CREATININE-S ASSAY

Chemistry · 169d

Cleared Feb 18, 1994

CHLORIDE (MF) ASSAY

Chemistry · 148d