VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
FDA premarket approval N50510/S080 · decided 1998-04-14
Approval details
- PMA number
- N50510
- Supplement
- S080
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
- Generic name
- Susceptibility test cards, antimicrobial
- Applicant
- Biomerieux Vitek, Inc.
- Date received
- 1998-04-01
- Decision date
- 1998-04-14
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- LTW
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Approval for the addition of a limitation to use an alternative method to confirm results for the testing of Pseudomonas aeruginosa with the antibiotic cefepime. The device, as modified, will be marketed under the trade name Vitek Gram Negative Susceptibility Card in three concentrations (equivalent to 4, 8 and 16 ug/ml) and is indciated for the testing of rapidly growing aerobic and/or facultatively anaerobic gram negative bacilli.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |