510(k) K885110
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1989
- Date Received
- December 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, Febrile (Weil-Felix), All Groups
- Device Class
- Class I
- Regulation Number
- 866.3410
- Review Panel
- MI
- Submission Type