510(k) K883185
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1988
- Date Received
- July 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hematocrit, Tube, Rack, Sealer, Holder
- Device Class
- Class II
- Regulation Number
- 864.6400
- Review Panel
- HE
- Submission Type