Diazyme Laboratories - FDA 510(k) Cleared Devices

Cleared Jan 11, 2018

Diazyme EZ Vitamin D Assay

K172992 · MRG

Chemistry · 106d

Cleared Aug 18, 2017

Diazyme DZ-Lite Total beta-hCG Test System

K163418 · DHA

Chemistry · 255d

Cleared Nov 21, 2016

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c...

K160762 · LCP

Chemistry · 245d

Cleared Nov 04, 2016

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

K161646 · CGN

Chemistry · 142d

Cleared Sep 20, 2016

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme...

K161721 · CDD

Chemistry · 90d

Cleared Aug 06, 2014

DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT

K133803 · LCP

Chemistry · 233d

Cleared Mar 14, 2014

DIAZYME 25-OH VITAMIN D ASSAY

K133410 · MRG

Chemistry · 127d

Cleared Jun 26, 2013

DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET

K131556 · JIT

Chemistry · 28d

Cleared Jun 07, 2013

DIAZYME MYOGLOBIN

K123785 · DDR

Chemistry · 179d

Cleared Nov 28, 2012

DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL...

K122420 · MRG

Chemistry · 111d

Cleared Sep 21, 2012

DIAZYME HSCRP POC TEST KIT

K121558 · DCK

Chemistry · 115d

Cleared Jul 31, 2012

DIAZYME HOMOCYSTEINE POC TEST KIT

K121053 · LPS

Chemistry · 116d