REP(R) SPE TEMPLATE 30, 16, & 8

Electrophoretic, Protein Fractionation

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep(r) Spe Template 30, 16, & 8.

Pre-market Notification Details

Device IDK913807
510k NumberK913807
Device Name:REP(R) SPE TEMPLATE 30, 16, & 8
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 Received1991-08-26
Decision Date1991-11-27

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