Submission Details
| 510(k) Number | K161810 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2016 |
| Decision Date | February 09, 2017 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
Feb 2017
Decision
223d
Days
Class 1
Risk
About This 510(k) Submission
K161810 is an FDA 510(k) clearance for the BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by Becton Dickinson (Sparks, US). The FDA issued a Cleared decision on February 9, 2017, 223 days after receiving the submission on July 1, 2016. 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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