510(k) K980375
K980375 is an FDA 510(k) premarket notification submitted by Applied Imaging Corp. for the device "WINSCAN AUTOMATED IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 9, 1998. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Applied Imaging Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1998
- Date Received
- January 30, 1998
- 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