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 Soybean-casein Digest Broth With Resins In A Plastic Vial.
Device ID | K173873 |
510k Number | K173873 |
Device Name: | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth With Resins In A Plastic Vial |
Classification | System, Blood Culturing |
Applicant | Becton Dickinson And Company 7 Loveton Circle MC:694 Sparks, MD 21152 |
Contact | Ashanti Brown |
Correspondent | Ashanti 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 | 2017-12-20 |
Decision Date | 2018-03-16 |
Summary: | summary |