510(k) K924167
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1993
- Date Received
- August 19, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Hematocrit Measuring
- Device Class
- Class II
- Regulation Number
- 864.6400
- Review Panel
- HE
- Submission Type