510(k) K980375

WINSCAN AUTOMATED IMAGING SYSTEM by Applied Imaging Corp. — Product Code JOY

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