REP SPE PLUS (PONCEAU S) SYSTEM

Electrophoretic, Protein Fractionation

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Spe Plus (ponceau S) System.

Pre-market Notification Details

Device IDK922053
510k NumberK922053
Device Name:REP SPE PLUS (PONCEAU S) SYSTEM
ClassificationElectrophoretic, Protein Fractionation
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPat Franks
CorrespondentPat Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeCEF  
CFR Regulation Number862.1630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-04
Decision Date1992-08-18

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