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Diazyme Laboratories

41 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Diazyme EZ Vitamin D Assay (K172992)Diazyme Laboratories2018-01-11
Diazyme DZ-Lite Total beta-hCG Test System (K163418)Diazyme Laboratories2017-08-18
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set (K162297)Diazyme Laboratories2017-04-18
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set (K160762)Diazyme Laboratories2016-11-21
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 (K153394)Diazyme Laboratories2016-11-18
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set (K161646)Diazyme Laboratories2016-11-04
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set (K161721)Diazyme Laboratories2016-09-20
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set (K143470)Diazyme Laboratories2016-01-31
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT (K133803)Diazyme Laboratories2014-08-06
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET (K133083)Diazyme Laboratories2014-06-24
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET (K133410)Diazyme Laboratories2014-03-14
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET (K131556)Diazyme Laboratories2013-06-26
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (K123785)Diazyme Laboratories2013-06-07
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET (K112120)Diazyme Laboratories2013-01-24
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA (K122420)Diazyme Laboratories2012-11-28
DIAZYME HSCRP POC TEST KIT (K121558)Diazyme Laboratories2012-09-21
DIAZYME HOMOCYSTEINE POC TEST KIT (K121053)Diazyme Laboratories2012-07-31
DIAZYME CYSTATIN C POC TEST KIT (K111664)Diazyme Laboratories2012-03-30
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT (K110188)Diazyme Laboratories2011-05-17
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET (K103557)Diazyme Laboratories2011-04-27
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, (K102432)Diazyme Laboratories2011-01-14
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS (K102638)Diazyme Laboratories2010-11-30
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER (K092911)Diazyme Laboratories2010-04-26
DIAZYME CYSTATIN C ASSAY (K093680)Diazyme Laboratories2010-04-08
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL (K091455)Diazyme Laboratories2009-08-14
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (K082001)Diazyme Laboratories2008-12-05
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B (K082763)Diazyme Laboratories2008-11-12
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX (K073488)Diazyme Laboratories2008-03-07
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) (K072270)Diazyme Laboratories2008-02-01
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS (K072395)Diazyme Laboratories2008-01-03
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL (K071971)Diazyme Laboratories2007-09-17
DIAZYME CREATININE LIQUID REAGENTS ASSAY (K062105)Diazyme Laboratories2007-04-23
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON (K070734)Diazyme Laboratories2007-04-09
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A (K060619)Diazyme Laboratories2006-07-21
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR (K061296)Diazyme Laboratories2006-06-13
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A (K053566)Diazyme Laboratories2006-02-15
TOTAL BILE ACIDS ASSAY, MODEL DZ042A (K051714)Diazyme Laboratories2005-12-07
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT (K042193)Diazyme Laboratories2004-10-29
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT (K042191)Diazyme Laboratories2004-10-29
DIAZYME SODIUM ENZYMATIC ASSAY (K042189)Diazyme Laboratories2004-10-07
HOMOCYSTEINE MICROTITER PLATE ASSAY (K032012)Diazyme Laboratories2003-09-03

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