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

Cleared Apr 27, 1998

HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51

K980772 · LBR

Chemistry · 66d

Cleared Apr 21, 1998

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

K980770 · LBR

Chemistry · 60d

Cleared Mar 11, 1998

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

K973999 · CGS

Chemistry · 141d

Cleared Mar 02, 1998

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

K973108 · CEK

Chemistry · 195d

Cleared Feb 12, 1998

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

K980316 · CJE

Chemistry · 16d

Cleared Jan 30, 1998

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

K974858 · CEO

Chemistry · 32d

Cleared Jan 22, 1998

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

K974859 · CFJ

Chemistry · 24d

Cleared Dec 08, 1997

AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10

K974053 · JFJ

Chemistry · 42d

Cleared Dec 05, 1997

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

K974003 · CKA

Chemistry · 45d

Cleared Nov 24, 1997

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

K973931 · CDQ

Chemistry · 40d

Cleared Nov 13, 1997

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

K974001 · CIT

Chemistry · 23d

Cleared Nov 04, 1997

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

K973933 · JIY

Chemistry · 20d

Cleared Nov 04, 1997

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

K974000 · JQB

Chemistry · 14d

Cleared Aug 08, 1997

DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA

K972337 · JIR

Chemistry · 46d

Cleared Aug 27, 1996

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

K955880 · CIG

Chemistry · 243d

Cleared Aug 27, 1996

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

K961587 · JMO

Chemistry · 125d

Cleared Aug 20, 1996

UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY

K963116 · JMO

Chemistry · 8d

Cleared Aug 16, 1996

TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60

K961281 · CDT

Chemistry · 135d

Cleared Jul 23, 1996

URIC ACID-SL ASSAY CATALOGUE NO. 237-60

K961586 · KNK

Chemistry · 90d

Cleared Jun 21, 1996

GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60

K961282 · CFR

Chemistry · 79d

Cleared Apr 01, 1996

TRUE TRIGLYCERIDE

K960088 · CDT

Chemistry · 81d

Cleared Feb 23, 1996

URIC ACID CATALOGE# 220-93/94/97

K955496 · KNK

Chemistry · 84d

Cleared Jun 09, 1995

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05

K945800 · JQB

Chemistry · 193d

Cleared Feb 08, 1995

CATALOGUE NUMBER 321-07/15/50

K945243 · JFJ

Chemistry · 104d

Cleared Aug 24, 1994

CK-MB ASSAY, CATALOGUE NUMBER 317-10

K942773 · CGS

Chemistry · 72d