510(k) K924395
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 1992
- Date Received
- August 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf, Typhus Fever Group
- Device Class
- Class I
- Regulation Number
- 866.3500
- Review Panel
- MI
- Submission Type