THERATEST LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14213461421346THERATEST LABORATORIES, INC.1N2026-01-011120 N Du Page Ave Lombard IL US 60148

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
314521342012357K973882EL-B2GP1SCRMSV1997-12-05
314521460264203K972790THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCRMSV1997-12-05
314521805670379K962050THERATEST EL-RFSCRDHR1996-12-16
314521110922227K955481THERATEST KIT (MODIFICATION)LJM1996-03-06
314521299230575K954106THERATEST LAB, INC., EL-ANASCR KITLJM1995-11-14
314521822697648K941398EL-RF/3 (IGM-IGG-IGA) KITDHR1995-07-28
314521694803197K933712EL-RF TEST SYSTEM: EL-RF-IGM KITDHR1994-01-28
314521412309209K092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRMSV2009-10-09
314521091033562K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120JZO2009-09-03
314521979616812K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120JZO2009-09-03
314521048333610K090753THERATEST EL-ANTI-CCP/2NHX2010-03-05
314521770999955K071692THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMSMVM2007-11-05
314521063045562K061376EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3MOB2006-07-20
314522015917235K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGAMID2006-02-07
314521982815794K051066THERATEST EL-ANA PROFILESLKP2005-10-07
314521948046132K040291EL-ANA PROFILES: ANTI-CHROMATINLJM2004-03-11
314521467118927K024151EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN PMQA2003-02-06
314521639809755K024031THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERELJM2003-02-06
314521927243168

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJM42004-03-11
MSV32009-10-09
DHR31996-12-16
JZO22009-09-03
NHX12010-03-05
MVM12007-11-05
MOB12006-07-20
MID12006-02-07
LKP12005-10-07
MQA12003-02-06

PMN#