510(k) K864201
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1987
- Date Received
- October 27, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2300
- Review Panel
- CH
- Submission Type