510(k) K884217
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1988
- Date Received
- October 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5420
- Review Panel
- IM
- Submission Type