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510(k) K864955

CYTOSCAN by Image Recognition Systems , Ltd. — Product Code LNJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1987
Date Received
December 18, 1986
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

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