Diazyme Laboratories - FDA 510(k) Cleared Devices
41
Total
41
Cleared
0
Denied
41 devices
Cleared
Dec 05, 2008
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
Toxicology
144d
Cleared
Nov 12, 2008
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
Chemistry
51d
Cleared
Mar 07, 2008
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X
Chemistry
137d
Cleared
Feb 01, 2008
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS...
Chemistry
170d
Cleared
Jan 03, 2008
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
Chemistry
129d
Cleared
Sep 17, 2007
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S)...
Chemistry
62d
Cleared
Apr 23, 2007
DIAZYME CREATININE LIQUID REAGENTS ASSAY
Chemistry
273d
Cleared
Apr 09, 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL,...
Chemistry
24d
Cleared
Jul 21, 2006
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
Chemistry
135d
Cleared
Jun 13, 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE...
Chemistry
35d
Cleared
Feb 15, 2006
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
Chemistry
55d
Cleared
Dec 07, 2005
TOTAL BILE ACIDS ASSAY, MODEL DZ042A
Chemistry
163d
Cleared
Oct 29, 2004
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
Chemistry
78d
Cleared
Oct 29, 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
Chemistry
78d
Cleared
Oct 07, 2004
DIAZYME SODIUM ENZYMATIC ASSAY
Chemistry
56d
Cleared
Sep 03, 2003
HOMOCYSTEINE MICROTITER PLATE ASSAY
Chemistry
65d