510(k) K812212
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 1981
- Date Received
- August 5, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acridine Orange
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type