510(k) K934966
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1994
- Date Received
- October 15, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prealbumin, Fitc, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5060
- Review Panel
- IM
- Submission Type