510(k) K081825
K081825 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY". The FDA issued a decision of Substantially Equivalent on December 11, 2008. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2008
- Date Received
- June 27, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Reagents, Neisseria
- Device Class
- Class II
- Regulation Number
- 866.3390
- Review Panel
- MI
- Submission Type