VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN
FDA premarket approval N50510/S143 · decided 2001-06-13
Approval details
- PMA number
- N50510
- Supplement
- S143
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN
- Generic name
- Susceptibility test cards, antimicrobial
- Applicant
- Biomerieux Vitek, Inc.
- Date received
- 2000-12-18
- Decision date
- 2001-06-13
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LTW
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC GATIFLOXACIN AT CONCENTRATIONS OF 1, 4, AND 8 MCG/ML TO THE VITEK.GRAM POSITIVE SUSCEPTIBILITY PANEL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VITEK. GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN, AND IS INDICATED FOR USE IN VITEK. GRAM POSITIVE SUSCEPTIBILITY TEST CARDS FOR THE SUSCEPTIBILITY TESTING OF STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS SAPROPHYTICUS ISOLATES TO GATIFLOXACIN IN THE RANGE OF <=0.5 TO >=8 MCG/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 |