POLYSLIT IFE KIT

Immunoelectrophoretic, Immunoglobulins, (g, A, M)

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Polyslit Ife Kit.

Pre-market Notification Details

Device IDK990998
510k NumberK990998
Device Name:POLYSLIT IFE KIT
ClassificationImmunoelectrophoretic, Immunoglobulins, (g, A, M)
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 CodeCFF  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-25
Decision Date1999-06-28

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