510(k) K921536
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1993
- Date Received
- March 11, 1992
- 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