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Diazyme Laboratories

FDA 510(k) & PMA Approved Devices — 38 products

Total Devices38
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K172992 Diazyme EZ Vitamin D AssayMRG2018-01-11 View
510(k) K163418 Diazyme DZ-Lite Total beta-hCG Test SystemDHA2017-08-18 View
510(k) K162297 Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetPTF2017-04-18 View
510(k) K160762 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetLCP2016-11-21 View
510(k) K153394 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDFH2016-11-18 View
510(k) K161646 Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetCGN2016-11-04 View
510(k) K161721 Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetCDD2016-09-20 View
510(k) K143470 Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetGIS2016-01-31 View
510(k) K131556 DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETJIT2013-06-26 View
510(k) K123785 DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDDR2013-06-07 View
510(k) K112120 DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETGHH2013-01-24 View
510(k) K122420 DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIAMRG2012-11-28 View
510(k) K121558 DIAZYME HSCRP POC TEST KITDCK2012-09-21 View
510(k) K121053 DIAZYME HOMOCYSTEINE POC TEST KITLPS2012-07-31 View
510(k) K111664 DIAZYME CYSTATIN C POC TEST KITNDY2012-03-30 View
510(k) K110188 DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KITLCP2011-05-17 View
510(k) K103557 DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SETDCK2011-04-27 View
510(k) K102432 DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,MRG2011-01-14 View
510(k) K102638 DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORSJIT2010-11-30 View
510(k) K092911 SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZERJJX2010-04-26 View
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