510(k) K954784
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1996
- Date Received
- October 17, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test Reagents, Neisseria Gonorrhoeae Biochemical
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type