VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
FDA premarket approval N50510/S139 · decided 2000-06-26
Approval details
- PMA number
- N50510
- Supplement
- S139
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
- Generic name
- Susceptibility test cards, antimicrobial
- Applicant
- Biomerieux Vitek, Inc.
- Date received
- 2000-04-12
- Decision date
- 2000-06-26
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LTW
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304 AND 32/608 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF <=0.5/9.5 TO >=16/304
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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 |