The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast- Gram Postive Penicillin For Streptococcus Pneumoniae.
| Device ID | K113783 |
| 510k Number | K113783 |
| Device Name: | VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Contact | Elizabeth Landon |
| Correspondent | Elizabeth Landon BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-22 |
| Decision Date | 2012-08-07 |
| Summary: | summary |