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510(k) K964453

REP 3 FLUR SPE-60 KIT by Helena Laboratories — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
November 6, 1996
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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