FDA 510(k) Applications Submitted by TERRY MCGOVERN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K962549 |
06/28/1996 |
VIDAS CREATINE KINASE MB ASSAY 30-421 |
BIOMERIEUX VITEK, INC. |
| K972895 |
08/05/1997 |
VIDAS ROTAVIRUS (RTV) ASSAY |
BIOMERIEUX VITEK, INC. |
| K973819 |
10/07/1997 |
VIDAS D-DIMER (DD) ASSAY |
BIOMERIEUX VITEK, INC. |
| K964887 |
12/06/1996 |
VIDAS C. DIFFICILE TOXIN A II ASSAY |
BIOMERIEUX VITEK, INC. |
| K955627 |
12/11/1995 |
VIDAS CHLAMYDIA BLOCKING ASSAY |
BIOMERIEUX VITEK, INC. |
| K955647 |
12/12/1995 |
VIDAS ESTRADIOL II (E2II) ASSAY |
BIOMERIEUX VITEK, INC. |
| K965084 |
12/19/1996 |
VIDAS PROESTERONE (PRG) (30 409) |
BIOMERIEUX, INC. |
| K965092 |
12/19/1996 |
VIDAS ROTAVIRUS ASSAY |
BIOMERIEUX VITEK, INC. |
| K000177 |
01/20/2000 |
RENEGADE HI-FLO MICROCATHETER |
BOSTON SCIENTIFIC CORP. |
| K000570 |
02/22/2000 |
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA |
BOSTON SCIENTIFIC CORP. |
| K000798 |
03/13/2000 |
TALON BALLOON DILATION CATHETER |
BOSTON SCIENTIFIC CORP. |
| K993303 |
10/04/1999 |
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
| K993305 |
10/04/1999 |
TRANSLUMINAL BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
|
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