K173873 is an FDA 510(k) clearance for the BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial. This device is classified as a System, Blood Culturing (Class I - General Controls, product code MDB).
Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on March 16, 2018, 86 days after receiving the submission on December 20, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2560.
| 510(k) Number | K173873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2017 |
| Decision Date | March 16, 2018 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MDB — System, Blood Culturing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2560 |