Diazyme Laboratories

FDA Filings

This page includes the latest FDA filings for Diazyme Laboratories. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K172992 Diazyme Laboratories	Diazyme EZ Vitamin D Assay	2018-01-11
PMN K163418 Diazyme Laboratories	Diazyme DZ-Lite Total Beta-hCG Test System	2017-08-18
PMN K162297 Diazyme Laboratories	Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set	2017-04-18
PMN K160762 DIAZYME LABORATORIES	Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set	2016-11-21
PMN K153394 Diazyme Laboratories	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 Calibrator	2016-11-18
PMN K161646 DIAZYME LABORATORIES	Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set	2016-11-04
PMN K161721 Diazyme Laboratories	Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set	2016-09-20
PMN K143470 DIAZYME LABORATORIES	Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set	2016-01-31
PMN K133803 DIAZYME LABORATORIES	DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT	2014-08-06
PMN K133083 DIAZYME LABORATORIES	DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET	2014-06-24
PMN K133410 DIAZYME LABORATORIES	DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET	2014-03-14
PMN K131556 DIAZYME LABORATORIES	DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET	2013-06-26
PMN K123785 DIAZYME LABORATORIES	DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET	2013-06-07
PMN K112120 DIAZYME LABORATORIES	DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET	2013-01-24
PMN K122420 DIAZYME LABORATORIES	DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA	2012-11-28
PMN K121558 DIAZYME LABORATORIES	DIAZYME HSCRP POC TEST KIT	2012-09-21
PMN K121053 DIAZYME LABORATORIES	DIAZYME HOMOCYSTEINE POC TEST KIT	2012-07-31
PMN K111664 DIAZYME LABORATORIES	DIAZYME CYSTATIN C POC TEST KIT	2012-03-30
PMN K110188 DIAZYME LABORATORIES	DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT	2011-05-17
PMN K103557 DIAZYME LABORATORIES	DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET	2011-04-27
PMN K102432 DIAZYME LABORATORIES	DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,	2011-01-14
PMN K102638 DIAZYME LABORATORIES	DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS	2010-11-30
PMN K092911 DIAZYME LABORATORIES	SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER	2010-04-26
PMN K093680 DIAZYME LABORATORIES	DIAZYME CYSTATIN C ASSAY	2010-04-08
PMN K091455 DIAZYME LABORATORIES	DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL	2009-08-14
PMN K082001 DIAZYME LABORATORIES	DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B	2008-12-05
PMN K082763 DIAZYME LABORATORIES	DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B	2008-11-12
PMN K073488 DIAZYME LABORATORIES	DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX	2008-03-07
PMN K072270 DIAZYME LABORATORIES	DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)	2008-02-01
PMN K072395 DIAZYME LABORATORIES	DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS	2008-01-03
PMN K071971 DIAZYME LABORATORIES	DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL	2007-09-17
PMN K062105 DIAZYME LABORATORIES	DIAZYME CREATININE LIQUID REAGENTS ASSAY	2007-04-23
PMN K070734 DIAZYME LABORATORIES	MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON	2007-04-09
PMN K060619 DIAZYME LABORATORIES	DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A	2006-07-21
PMN K061296 DIAZYME LABORATORIES	DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR	2006-06-13
PMN K053566 DIAZYME LABORATORIES	MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A	2006-02-15
PMN K051714 DIAZYME LABORATORIES	TOTAL BILE ACIDS ASSAY, MODEL DZ042A	2005-12-07
PMN K042193 DIAZYME LABORATORIES	DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT	2004-10-29
PMN K042191 DIAZYME LABORATORIES	DIAZYME POTASSIUM ENZYMATIC ASSAY KIT	2004-10-29
PMN K042189 DIAZYME LABORATORIES	DIAZYME SODIUM ENZYMATIC ASSAY	2004-10-07
PMN K032012 DIAZYME LABORATORIES	HOMOCYSTEINE MICROTITER PLATE ASSAY	2003-09-03

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