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510(k) K912386

REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 by Helena Laboratories — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
April 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
Review Panel
CH
Submission Type

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