The following data is part of a premarket notification filed by Becton Dickinson with the FDA for Bd Bactec Standard/10 Aerobic/f Culture Vials Soybean-casein Digest Broth In A Plastic Vial.
| Device ID | K161810 |
| 510k Number | K161810 |
| Device Name: | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth In A Plastic Vial |
| Classification | System, Blood Culturing |
| Applicant | BECTON DICKINSON 7 LOVETON CIRCLE, MC 694 Sparks, MD 21152 |
| Contact | Ashanti C. Brown |
| Correspondent | Ashanti C. Brown BECTON DICKINSON 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 | 2016-07-01 |
| Decision Date | 2017-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904420278 | K161810 | 000 |