510(k) K864213
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1986
- Date Received
- October 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Alpha-2-Antiplasmin
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type