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510(k) K922053

REP SPE PLUS (PONCEAU S) SYSTEM by Helena Laboratories — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1992
Date Received
May 4, 1992
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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  • K951536 — HYDRAGEL PROTEIN(E) KIT (June 30, 1995)
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  • K922024 — REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (July 23, 1992)
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