FDA 510(k) Applications Submitted by THERATEST LABORATORIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K955481 |
11/15/1995 |
THERATEST KIT (MODIFICATION) |
THERATEST LABORATORIES, INC. |
| K090760 |
03/23/2009 |
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 |
THERATEST LABORATORIES, INC. |
| K051066 |
04/26/2005 |
THERATEST EL-ANA PROFILES |
THERATEST LABORATORIES, INC. |
| K060176 |
01/23/2006 |
EL-ACL SCREEN; EL-ACL IGM, IGG, IGA |
THERATEST LABORATORIES, INC. |
| K040291 |
02/06/2004 |
EL-ANA PROFILES: ANTI-CHROMATIN |
THERATEST LABORATORIES, INC. |
| K090753 |
03/20/2009 |
THERATEST EL-ANTI-CCP/2 |
THERATEST LABORATORIES, INC. |
| K982150 |
06/18/1998 |
EL-ANA PROFILES: EL-ENA/4 |
THERATEST LABORATORIES, INC. |
| K982622 |
06/18/1998 |
EL-ANA PROFILES: EL-ENA/5 |
THERATEST LABORATORIES, INC. |
| K071692 |
06/20/2007 |
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS |
THERATEST LABORATORIES, INC. |
| K972790 |
07/28/1997 |
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR |
THERATEST LABORATORIES, INC. |
| K002559 |
08/17/2000 |
EL-ANA PROFILES-2K1 |
THERATEST LABORATORIES, INC. |
| K973882 |
10/14/1997 |
EL-B2GP1SCR |
THERATEST LABORATORIES, INC. |
| K024031 |
12/06/2002 |
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE |
THERATEST LABORATORIES, INC. |
| K024151 |
12/06/2002 |
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P |
THERATEST LABORATORIES, INC. |
| K061376 |
05/17/2006 |
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 |
THERATEST LABORATORIES, INC. |
| K962050 |
05/28/1996 |
THERATEST EL-RFSCR |
THERATEST LABORATORIES, INC. |
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