510(k) K851372
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1985
- Date Received
- April 8, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Device Class
- Class II
- Regulation Number
- 866.3305
- Review Panel
- MI
- Submission Type