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510(k) K864557

710 PLUS by Ciba Corning Diagnostics Corp. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1987
Date Received
November 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type

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