VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE
FDA premarket approval N50510/S140 · decided 2001-03-09
Approval details
- PMA number
- N50510
- Supplement
- S140
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE
- Generic name
- Susceptibility test cards, antimicrobial
- Applicant
- Biomerieux Vitek, Inc.
- Date received
- 2000-11-16
- Decision date
- 2001-03-09
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- LTW
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC MINOCYCLINE AT CONCENTRATIONS OF 0.125, 0.5, AND 1 UG/ML TO THE VITEK(R) 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 AND INDICATED FOR USE IN VITEK(R) 2 GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF GRAM POSITIVE ISOLATES TO MINOCYCLINE IN THE RANGE OF <=0.5 TO >=16 UG/ML.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VIDAS D-DIMER (DD) ASSAY (K973819) | Biomerieux Vitek, Inc. | 1998-03-10 |
| VIDAS ROTAVIRUS (RTV) ASSAY (K972895) | Biomerieux Vitek, Inc. | 1997-10-03 |
| VIDAS ROTAVIRUS ASSAY (K965092) | Biomerieux Vitek, Inc. | 1997-05-05 |
| VIDAS C. DIFFICILE TOXIN A II ASSAY (K964887) | Biomerieux Vitek, Inc. | 1997-04-08 |
| VIDAS CHLAMYDIA BLOCKING ASSAY (K955627) | Biomerieux Vitek, Inc. | 1996-10-07 |
| VIDAS CREATINE KINASE MB ASSAY 30-421 (K962549) | Biomerieux Vitek, Inc. | 1996-08-30 |
| GRAM NEGATIVE IDENTIFICATION PLUS CARD (K962609) | Biomerieux Vitek, Inc. | 1996-08-30 |
| VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (K952095) | Biomerieux Vitek, Inc. | 1996-03-12 |