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510(k) K851619

GEN PROFILER SYSTEM by Electro-Cucleonics, Inc. — Product Code JJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1985
Date Received
April 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type

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