510(k) K872755

KARYOTEC 100 by Amcor Electronics, Ltd. — Product Code LNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1987
Date Received
July 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chromosome, Automated
Device Class
Class II
Regulation Number
864.5260
Review Panel
PA
Submission Type