510(k) K946373
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1996
- Date Received
- September 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Device Class
- Class I
- Regulation Number
- 866.3375
- Review Panel
- MI
- Submission Type