The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Pf Plus Culture Bottle.
| Device ID | K121446 |
| 510k Number | K121446 |
| Device Name: | BACT/ALERT PF PLUS CULTURE BOTTLE |
| Classification | System, Blood Culturing |
| 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 | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-15 |
| Decision Date | 2013-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026357924 | K121446 | 000 |