The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Bact/alert Mp Culture Bottles (plastic).
Device ID | K031737 |
510k Number | K031737 |
Device Name: | BACT/ALERT MP CULTURE BOTTLES (PLASTIC) |
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 | 2003-06-04 |
Decision Date | 2003-07-14 |
Summary: | summary |