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510(k) K900251

REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 by Helena Laboratories — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
January 17, 1990
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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