The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Fa Plus Culture Bottle.
Device ID | K121461 |
510k Number | K121461 |
Device Name: | BACT/ALERT FA PLUS CULTURE BOTTLE |
Classification | System, Blood Culturing |
Applicant | BIOMERIEUX, INC. 100 RODOLPHE ST Durham, NC 27712 |
Contact | Jocelyn Jennings |
Correspondent | Jocelyn Jennings 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 | 2012-05-17 |
Decision Date | 2013-01-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026357900 | K121461 | 000 |