510(k) K014123
K014123 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BACTEC MGIT 960 SIRE KITS". The FDA issued a decision of Substantially Equivalent on April 19, 2002. The device falls under product code MJA (Susceptibility Test Powders, Antimycobacterial), a Class II device regulated under 21 CFR 866.1640. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2002
- Date Received
- December 17, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Susceptibility Test Powders, Antimycobacterial
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type