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

FDA 510(k) Regulatory Record - Diagnostic Chemicals , Ltd. Chemistry ✕

52 devices

1-12 of 52

Cleared Jun 22, 2007

ENZYMATIC CREATININE ASSAY (265 SERIES)

Chemistry · 133d

Cleared Jan 19, 2007

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7

Chemistry · 88d

Cleared Apr 28, 2006

CRP-ADVANCE ASSAY, MODELS 250-20, 250-25

Chemistry · 99d

Cleared Apr 24, 2006

CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250

Chemistry · 95d

Cleared Nov 10, 2005

CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91

Chemistry · 134d

Cleared Jul 05, 2005

DCL MICROALBUMIN ASSAY, MODEL 252-20

Chemistry · 56d

Cleared Dec 27, 2004

MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50,...

Chemistry · 118d

Cleared Nov 23, 2004

HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278

Chemistry · 127d

Cleared Nov 23, 2004

LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40

Chemistry · 127d

Cleared Nov 23, 2004

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

Chemistry · 127d

Cleared Oct 04, 2004

MICROALBUMIN MULTI-CALIBRATOR SET

Chemistry · 46d

Cleared Mar 10, 2004

AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

Chemistry · 83d

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