VITEK 2 SYSTEM
FDA premarket approval N50510/S085 · decided 1999-07-09
Approval details
- PMA number
- N50510
- Supplement
- S085
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITEK 2 SYSTEM
- Generic name
- Susceptibility test cards, antimicrobial
- Applicant
- Biomerieux Vitek, Inc.
- Date received
- 1998-09-09
- Decision date
- 1999-07-09
- Days to decision
- 303 days
- Decision code
- APPR
- Product code
- LTW
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Approval for the addition of three antibiotics to the Gram Positive Susceptibility Card. The device is intended as laboratory aid in the determination of the in vitro susceptibility of aerobic gram positive bacteria when tested on a Gram Positive Susceptibility Test Card with varioius antimicrobial agents and concentrations.
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 |