The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Bactec Plus Anaerobic/f (plastic).
Device ID | K141810 |
510k Number | K141810 |
Device Name: | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) |
Classification | System, Blood Culturing |
Applicant | Becton, Dickinson And Company 7 Loveton Cir., MC 694 Sparks, MD 21152 |
Contact | Paul Swift |
Correspondent | Paul Swift Becton, Dickinson And Company 7 Loveton Cir., MC 694 Sparks, MD 21152 |
Product Code | MDB |
CFR Regulation Number | 866.2560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-07 |
Decision Date | 2014-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382904420223 | K141810 | 000 |