Diazyme Laboratories - FDA 510(k) Cleared Devices
41
Total
41
Cleared
0
Denied
Diazyme Laboratories has 41 FDA 510(k) cleared chemistry devices. Based in Irvine, US.
Historical record: 41 cleared submissions from 2003 to 2018.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Diazyme Laboratories
41 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
Apr 18, 2017
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator...
Microbiology
245d
Cleared
Nov 21, 2016
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c...
Chemistry
245d
Cleared
Nov 18, 2016
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
Immunology
360d
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
Jan 31, 2016
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme...
Hematology
422d
Cleared
Aug 06, 2014
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
Chemistry
233d
Cleared
Jun 24, 2014
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN...
Immunology
267d
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
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