Medical Device Manufacturer · US , Chicago , IL

Theratest Laboratories, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1991
22
Total
22
Cleared
0
Denied

Theratest Laboratories, Inc. has 22 FDA 510(k) cleared immunology devices. Based in Chicago, US.

Historical record: 22 cleared submissions from 1991 to 2010.

Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Theratest Laboratories, Inc.

22 devices
1-22 of 22
Cleared Mar 05, 2010
THERATEST EL-ANTI-CCP/2
K090753 · NHX
Immunology · 350d
Cleared Sep 03, 2009
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119,...
K090760 · JZO
Immunology · 164d
Cleared Nov 05, 2007
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
K071692 · MVM
Immunology · 138d
Cleared Jul 20, 2006
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
K061376 · MOB
Immunology · 64d
Cleared Feb 07, 2006
EL-ACL SCREEN
K060176 · MID
Immunology · 15d
Cleared Oct 07, 2005
THERATEST EL-ANA PROFILES
K051066 · LKP
Immunology · 164d
Cleared Mar 11, 2004
EL-ANA PROFILES: ANTI-CHROMATIN
K040291 · LJM
Immunology · 34d
Cleared Feb 06, 2003
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
K024031 · LJM
Immunology · 62d
Cleared Feb 06, 2003
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
K024151 · MQA
Immunology · 62d
Cleared Sep 12, 2000
EL-ANA PROFILES-2K1
K002559 · LJM
Immunology · 26d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/4
K982150 · LLL
Immunology · 56d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/5
K982622 · LLL
Immunology · 56d
Cleared Dec 05, 1997
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
K972790 · MSV
Immunology · 130d
Cleared Dec 05, 1997
EL-B2GP1SCR
K973882 · MSV
Immunology · 52d
Cleared Dec 16, 1996
THERATEST EL-RFSCR
K962050 · DHR
Immunology · 202d
Cleared Mar 06, 1996
THERATEST KIT (MODIFICATION)
K955481 · LJM
Immunology · 112d
Cleared Nov 14, 1995
THERATEST LAB, INC., EL-ANASCR KIT
K954106 · LJM
Immunology · 105d
Cleared Sep 26, 1995
THERATEST EL-ANA PROFILES TEST SYSTEM
K950716 · LJM
Immunology · 238d
Cleared Jul 28, 1995
EL-RF/3 (IGM-IGG-IGA) KIT
K941398 · DHR
Immunology · 493d
Cleared Jan 28, 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · DHR
Immunology · 182d
Cleared May 22, 1992
THE THERATEST EL-ANA PROFILES
K914454 · LKJ
Immunology · 228d
Cleared Jan 14, 1991
THE THERATEST ACA TEST
K905301 · GFO
Immunology · 48d
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