510(k) K922858
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 16, 1992
- Date Received
- June 15, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vacuum Sample, With Anticoagulant
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type