VITEK 2 SYSTEM
FDA premarket approval N50510/S082 · decided 1999-06-16
Approval details
- PMA number
- N50510
- Supplement
- S082
- 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
- 1998-07-01
- Decision date
- 1999-06-16
- Days to decision
- 350 days
- Decision code
- APPR
- Product code
- LTW
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Hazelwood, MO
- Statement
- Approval for major modifications to the design of the device in order to automate manual operations and enhance its performance. The device as modified will be marketed under the trade name VITEK(R) 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of aerobic gram negative bacilli when tested on a Gram Negative Susceptibility Test Card.
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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 |