The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Fa Culture Bottle.
| Device ID | K020813 |
| 510k Number | K020813 |
| Device Name: | BACT/ALERT FA CULTURE BOTTLE |
| Classification | System, Blood Culturing |
| Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
| Contact | Ron Sanyal |
| Correspondent | Ron Sanyal 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 | 2002-03-13 |
| Decision Date | 2002-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026611811 | K020813 | 000 |