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.

22 devices
1–12 of 22
THERATEST EL-ANTI-CCP/2
K090753 · NHX Antibodies, Anti-cyclic Citrullinated Peptide (ccp) · Immunology
Mar 2010 350d
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
K090760 · JZO System, Test, Thyroid Autoantibody · Immunology
Sep 2009 164d
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
K071692 · MVM Autoantibodies, Endomysial(tissue Transglutaminase) · Immunology
Nov 2007 138d
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
K061376 · MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca) · Immunology
Jul 2006 64d
EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
K060176 · MID System, Test, Anticardiolipin Immunological · Immunology
Feb 2006 15d
THERATEST EL-ANA PROFILES
K051066 · LKP Anti-sm Antibody, Antigen And Control · Immunology
Oct 2005 164d
EL-ANA PROFILES: ANTI-CHROMATIN
K040291 · LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls · Immunology
Mar 2004 34d
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
K024031 · LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls · Immunology
Feb 2003 62d
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
K024151 · MQA Anti-ribosomal P Antibodies · Immunology
Feb 2003 62d
EL-ANA PROFILES-2K1
K002559 · LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls · Immunology
Sep 2000 26d
EL-ANA PROFILES: EL-ENA/4
K982150 · LLL Extractable Antinuclear Antibody, Antigen And Control · Immunology
Aug 1998 56d
EL-ANA PROFILES: EL-ENA/5
K982622 · LLL Extractable Antinuclear Antibody, Antigen And Control · Immunology
Aug 1998 56d
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