510(k) K072643
K072643 is an FDA 510(k) premarket notification submitted by Olympus Corporation for the device "CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US". The FDA issued a decision of Substantially Equivalent on November 16, 2007. The device falls under product code KZN (Scanner, Color), a Class II device regulated under 21 CFR 872.3661. Olympus Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2007
- Date Received
- September 18, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scanner, Color
- Device Class
- Class II
- Regulation Number
- 872.3661
- Review Panel
- DE
- Submission Type