510(k) K941712
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1994
- Date Received
- April 6, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescence Polarization Immunoassay, Amibacin
- Device Class
- Class II
- Regulation Number
- 862.3035
- Review Panel
- TX
- Submission Type