510(k) K083572
K083572 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD BACTEC Plus Aerobic/F Culture Vials". The FDA issued a decision of Substantially Equivalent on December 24, 2008. The device falls under product code MDB (System, Blood Culturing), a Class I device regulated under 21 CFR 866.2560. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 2008
- Date Received
- December 3, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Blood Culturing
- Device Class
- Class I
- Regulation Number
- 866.2560
- Review Panel
- MI
- Submission Type