510(k) K880544
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1988
- Date Received
- February 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Romanowsky Stains
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- HE
- Submission Type