510(k) K905493
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1991
- Date Received
- December 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, All Mycoplasma Spp.
- Device Class
- Class I
- Regulation Number
- 866.3375
- Review Panel
- MI
- Submission Type