510(k) K944417
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1995
- Date Received
- September 6, 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