510(k) K071398
K071398 is an FDA 510(k) premarket notification submitted by Applied Spectral Imaging , Ltd. for the device "SCANVIEW, MODEL SC-300". The FDA issued a decision of Substantially Equivalent on October 4, 2007. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Applied Spectral Imaging , Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2007
- Date Received
- May 21, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Automated Cell-Locating
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- HE
- Submission Type