Submission Details
| 510(k) Number | K222559 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2022 |
| Decision Date | March 24, 2023 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BD BACTEC? Myco/F Lytic Culture Vials
Mar 2023
Decision
212d
Days
Class 1
Risk
About This 510(k) Submission
K222559 is an FDA 510(k) clearance for the BD BACTEC? Myco/F Lytic Culture Vials, 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 24, 2023, 212 days after receiving the submission on August 24, 2022. 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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