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

26-50 of 66

Cleared Feb 01, 2000

IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15

Chemistry · 64d

Cleared Jan 18, 2000

ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17

Toxicology · 61d

Cleared Oct 18, 1999

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50

Chemistry · 25d

Cleared Apr 20, 1999

CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50

Chemistry · 43d

Cleared Sep 14, 1998

CARBON DIOXIDE-SL ASSAY, CAT # 253-01

Chemistry · 14d

Cleared Jun 29, 1998

SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40

Toxicology · 32d

Cleared Jun 03, 1998

BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30

Chemistry · 29d

Cleared May 12, 1998

ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.

Toxicology · 50d

Cleared Apr 27, 1998

HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51

Chemistry · 66d

Cleared Apr 21, 1998

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51

Chemistry · 60d

Cleared Apr 01, 1998

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12

Toxicology · 162d

Cleared Mar 11, 1998

CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30

Chemistry · 141d

Cleared Mar 03, 1998

ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10

Toxicology · 57d

Cleared Mar 02, 1998

TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50

Chemistry · 195d

Cleared Mar 02, 1998

SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71

Toxicology · 56d

Cleared Feb 12, 1998

ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30

Chemistry · 16d

Cleared Jan 30, 1998

PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30

Chemistry · 32d

Cleared Jan 22, 1998

LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30

Chemistry · 24d

Cleared Dec 08, 1997

AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10

Chemistry · 42d

Cleared Dec 05, 1997

ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30

Chemistry · 45d

Cleared Nov 24, 1997

UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30

Chemistry · 40d

Cleared Nov 13, 1997

ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30

Chemistry · 23d

Cleared Nov 04, 1997

SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30

Chemistry · 20d

Cleared Nov 04, 1997

Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30

Chemistry · 14d

Cleared Aug 08, 1997

DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA

Chemistry · 46d