Theratest Laboratories, Inc. - FDA 510(k) Cleared Devices
Recent clearances: THERATEST EL-ANTI-CCP/2, THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120, THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Theratest Laboratories, Inc. Immunology ✕
22 devices
Cleared
Mar 05, 2010
THERATEST EL-ANTI-CCP/2
Immunology
350d
Cleared
Sep 03, 2009
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119,...
Immunology
164d
Cleared
Nov 05, 2007
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
Immunology
138d
Cleared
Jul 20, 2006
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
Immunology
64d
Cleared
Feb 07, 2006
EL-ACL SCREEN
Immunology
15d
Cleared
Oct 07, 2005
THERATEST EL-ANA PROFILES
Immunology
164d
Cleared
Mar 11, 2004
EL-ANA PROFILES: ANTI-CHROMATIN
Immunology
34d
Cleared
Feb 06, 2003
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
Immunology
62d
Cleared
Feb 06, 2003
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
Immunology
62d
Cleared
Sep 12, 2000
EL-ANA PROFILES-2K1
Immunology
26d
Cleared
Aug 13, 1998
EL-ANA PROFILES: EL-ENA/4
Immunology
56d
Cleared
Aug 13, 1998
EL-ANA PROFILES: EL-ENA/5
Immunology
56d