Diazyme Laboratories - FDA 510(k) Cleared Devices
Recent clearances: Diazyme EZ Vitamin D Assay, Diazyme DZ-Lite Total beta-hCG Test System, Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
41
Total
41
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diazyme Laboratories Chemistry ✕
35 devices
Cleared
Jan 11, 2018
Diazyme EZ Vitamin D Assay
Chemistry
106d
Cleared
Aug 18, 2017
Diazyme DZ-Lite Total beta-hCG Test System
Chemistry
255d
Cleared
Nov 21, 2016
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c...
Chemistry
245d
Cleared
Nov 04, 2016
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
Chemistry
142d
Cleared
Sep 20, 2016
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme...
Chemistry
90d
Cleared
Aug 06, 2014
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
Chemistry
233d
Cleared
Mar 14, 2014
DIAZYME 25-OH VITAMIN D ASSAY
Chemistry
127d
Cleared
Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
Chemistry
28d
Cleared
Jun 07, 2013
DIAZYME MYOGLOBIN
Chemistry
179d
Cleared
Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL...
Chemistry
111d
Cleared
Sep 21, 2012
DIAZYME HSCRP POC TEST KIT
Chemistry
115d
Cleared
Jul 31, 2012
DIAZYME HOMOCYSTEINE POC TEST KIT
Chemistry
116d