Submission Details
| 510(k) Number | K173873 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
Mar 2018
Decision
86d
Days
Class 1
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 866.2560.
Device Classification
| Product Code | MDB — System, Blood Culturing |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2560 |
Manufacturer
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