Diazyme Laboratories - FDA 510(k) Cleared Devices

Cleared Apr 23, 2007

DIAZYME CREATININE LIQUID REAGENTS ASSAY

K062105 · JFY

Chemistry · 273d

Cleared Apr 09, 2007

MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL,...

K070734 · LCP

Chemistry · 24d

Cleared Jul 21, 2006

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A

K060619 · KHS

Chemistry · 135d

Cleared Jun 13, 2006

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE...

K061296 · LPS

Chemistry · 35d

Cleared Feb 15, 2006

MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A

K053566 · MZV

Chemistry · 55d

Cleared Dec 07, 2005

TOTAL BILE ACIDS ASSAY, MODEL DZ042A

K051714 · KWW

Chemistry · 163d

Cleared Oct 29, 2004

DIAZYME POTASSIUM ENZYMATIC ASSAY KIT

K042191 · MZV

Chemistry · 78d

Cleared Oct 29, 2004

DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT

K042193 · LCP

Chemistry · 78d

Cleared Oct 07, 2004

DIAZYME SODIUM ENZYMATIC ASSAY

K042189 · MZU

Chemistry · 56d

Cleared Sep 03, 2003

HOMOCYSTEINE MICROTITER PLATE ASSAY

K032012 · LPS

Chemistry · 65d