510(k) K850260
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1985
- Date Received
- January 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- Device Class
- Class I
- Regulation Number
- 862.2400
- Review Panel
- CH
- Submission Type