VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN
FDA premarket approval N50510/S104 · decided 2000-01-06
Approval details
- PMA number
- N50510
- Supplement
- S104
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN
- Generic name
- Susceptibility test cards, antimicrobial
- Applicant
- Biomerieux Vitek, Inc.
- Date received
- 1999-08-20
- Decision date
- 2000-01-06
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- LTW
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Approval for the addition of the antibiotic gentamicin at concentrations of 4, 16, and 32 ug/ml to the Viteck 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek 2 and is indicated for use in Vitek 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to gentamicin in the range of <=1 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 |