The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Bactec Peds Plus/f Culture Vials (plastic).
Device ID | K151866 |
510k Number | K151866 |
Device Name: | BD BACTEC Peds Plus/F Culture Vials (plastic) |
Classification | System, Blood Culturing |
Applicant | BECTON DICKINSON AND COMPANY 7 LOVETON CIRCLE, MC 694 Sparks, MD 21152 |
Contact | Ashanti C. Brown |
Correspondent | Ashanti C. Brown BECTON DICKINSON AND COMPANY 7 LOVETON CIRCLE, 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 | 2015-07-09 |
Decision Date | 2016-02-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382904420209 | K151866 | 000 |