FDA.reportPublic FDA data

Diazyme Laboratories, Inc.

Matched from indexed company URL: DIAZYME LABORATORIES

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20329003004445302Diazyme Laboratories, Inc.1N2026-01-0112889 GREGG CT POWAY CA US 92064

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
218551135820216K220763ALPCO Calprotectin Immunoturbidimetric AssayNXO2023-04-13
218551668510837K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDFH2018-06-26
218551093128507K180209Diazyme 1,5-AG AssayNOZ2018-10-04
218551854653979K180074Diazyme Lipoprotein (a) AssayDFC2018-03-22
218551632072952K172992Diazyme EZ Vitamin D AssayMRG2018-01-11
218551684664947K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetPTF2017-04-18
218551776831665K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetCDD2016-09-20
218551014621068K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetCGN2016-11-04
218551948916215K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetLCP2016-11-21
218551448031191K143470Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control SetGIS2016-01-31
218551519260669K141575PLAC TEST FOR LP-PLA2 ACTIVITYNOE2014-12-15
218551018772422K133410DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SETMRG2014-03-14
218551912220118K131556DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SETJIT2013-06-26
218551705252348K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDDR2013-06-07
218552059596840K113793HOMOCYSTEINE TESTLPS2012-06-05
218551588146567K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETGHH2013-01-24
218551947152756K110188DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KITLCP2011-05-17
218551996744983K103557DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SETDCK2011-04-27
218551413416988K103531PRESTIGE 24I; BIOLIS 24I; MGC 240CFR2011-12-01
218551804819594K093680DIAZYME CYSTATIN C ASSAYNDY2010-04-08
218551824303097K091455DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CALMZV2009-08-14
218551784365691K082763DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114BMZU2008-11-12
218551543837468K082001DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BJII2008-12-05
218551148332722K073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXMSJ2008-03-07
218551865531660K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYMSJ2008-07-16
218551584672082K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSLBR2008-01-22
218551253507493K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSLBS2008-01-03
218552064175411K071971DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CALLPS2007-09-17
218551187991251K070734MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CONLCP2007-04-09
218551185234302K062105DIAZYME CREATININE LIQUID REAGENTS ASSAYJFY2007-04-23
218551339716249K060619DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122AKHS2006-07-21
218551060398575K051714TOTAL BILE ACIDS ASSAY, MODEL DZ042AKWW2005-12-07
218551788071086K042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITJJX2004-10-29
218551034939674
218551156872421
218551277672950
218551614181007
218551923568587
218552048334056
218552058000857

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCP32016-11-21
MRG22018-01-11
LPS22012-06-05
MSJ22008-07-16
NXO12023-04-13
NOZ12018-10-04
DFH12018-06-26
DFC12018-03-22
PTF12017-04-18
CGN12016-11-04
CDD12016-09-20
GIS12016-01-31
NOE12014-12-15
JIT12013-06-26
DDR12013-06-07
GHH12013-01-24
CFR12011-12-01
DCK12011-04-27
NDY12010-04-08
MZV12009-08-14
JII12008-12-05
MZU12008-11-12
LBR12008-01-22
LBS12008-01-03
JFY12007-04-23
KHS12006-07-21
KWW12005-12-07
JJX12004-10-29

PMN#

48 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next