FDA 510(k) Applications Submitted by NIKITA S MAPP
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080017 |
01/03/2008 |
VIDAS AFP ASSAY |
BIOMERIEUX, INC. |
| K080194 |
01/25/2008 |
VIDAS CEA (S) ASSAY |
BIOMERIEUX, INC. |
| K080469 |
02/21/2008 |
VIDAS CA 15-3 ASSAY |
BIOMERIEUX, INC. |
| K080766 |
03/18/2008 |
VIDAS RUB IGG |
BIOMERIEUX, INC. |
| K080931 |
04/02/2008 |
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY |
BIOMERIEUX, INC. |
| K071146 |
04/24/2007 |
VIDAS B.R.A.H.M.S. PCT ASSAY |
BIOMERIEUX, INC. |
| K072138 |
08/02/2007 |
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 |
BIOMERIEUX, INC. |
| K063243 |
10/26/2006 |
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 |
BIOMERIEUX, INC. |
| K073091 |
11/01/2007 |
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 |
BIOMERIEUX, INC. |
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