FDA 510(k) Applications Submitted by Diazyme Laboratories
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110188 |
01/24/2011 |
DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT |
DIAZYME LABORATORIES |
| K070734 |
03/16/2007 |
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON |
DIAZYME LABORATORIES |
| K160762 |
03/21/2016 |
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set |
DIAZYME LABORATORIES |
| K121053 |
04/06/2012 |
DIAZYME HOMOCYSTEINE POC TEST KIT |
DIAZYME LABORATORIES |
| K091455 |
05/18/2009 |
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL |
DIAZYME LABORATORIES |
| K121558 |
05/29/2012 |
DIAZYME HSCRP POC TEST KIT |
DIAZYME LABORATORIES |
| K131556 |
05/29/2013 |
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET |
DIAZYME LABORATORIES |
| K111664 |
06/14/2011 |
DIAZYME CYSTATIN C POC TEST KIT |
DIAZYME LABORATORIES |
| K161646 |
06/15/2016 |
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set |
DIAZYME LABORATORIES |
| K161721 |
06/22/2016 |
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set |
Diazyme Laboratories |
| K082001 |
07/14/2008 |
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B |
DIAZYME LABORATORIES |
| K062105 |
07/24/2006 |
DIAZYME CREATININE LIQUID REAGENTS ASSAY |
DIAZYME LABORATORIES |
| K112120 |
07/25/2011 |
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET |
DIAZYME LABORATORIES |
| K122420 |
08/09/2012 |
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA |
DIAZYME LABORATORIES |
| K162297 |
08/16/2016 |
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set |
Diazyme Laboratories |
| K102432 |
08/26/2010 |
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, |
DIAZYME LABORATORIES |
| K102638 |
09/14/2010 |
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS |
DIAZYME LABORATORIES |
| K082763 |
09/22/2008 |
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B |
DIAZYME LABORATORIES |
| K092911 |
09/22/2009 |
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER |
DIAZYME LABORATORIES |
| K172992 |
09/27/2017 |
Diazyme EZ Vitamin D Assay |
Diazyme Laboratories |
| K133083 |
09/30/2013 |
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET |
DIAZYME LABORATORIES |
| K133410 |
11/07/2013 |
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET |
DIAZYME LABORATORIES |
| K153394 |
11/24/2015 |
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 |
Diazyme Laboratories |
| K093680 |
11/27/2009 |
DIAZYME CYSTATIN C ASSAY |
DIAZYME LABORATORIES |
| K103557 |
12/02/2010 |
DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET |
DIAZYME LABORATORIES |
| K143470 |
12/05/2014 |
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set |
DIAZYME LABORATORIES |
| K163418 |
12/06/2016 |
Diazyme DZ-Lite Total beta-hCG Test System |
Diazyme Laboratories |
| K123785 |
12/10/2012 |
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET |
DIAZYME LABORATORIES |
| K133803 |
12/16/2013 |
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT |
DIAZYME LABORATORIES |
| K071971 |
07/17/2007 |
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL |
DIAZYME LABORATORIES |
| K072270 |
08/15/2007 |
DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) |
DIAZYME LABORATORIES |
| K072395 |
08/27/2007 |
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS |
DIAZYME LABORATORIES |
| K073488 |
10/22/2007 |
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX |
DIAZYME LABORATORIES |
| K042193 |
08/12/2004 |
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT |
DIAZYME LABORATORIES |
| K032012 |
06/30/2003 |
HOMOCYSTEINE MICROTITER PLATE ASSAY |
DIAZYME LABORATORIES |
| K051714 |
06/27/2005 |
TOTAL BILE ACIDS ASSAY, MODEL DZ042A |
DIAZYME LABORATORIES |
| K042191 |
08/12/2004 |
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT |
DIAZYME LABORATORIES |
| K053566 |
12/22/2005 |
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A |
DIAZYME LABORATORIES |
| K042189 |
08/12/2004 |
DIAZYME SODIUM ENZYMATIC ASSAY |
DIAZYME LABORATORIES |
| K060619 |
03/08/2006 |
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A |
DIAZYME LABORATORIES |
| K061296 |
05/09/2006 |
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR |
DIAZYME LABORATORIES |
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