EPINEPHRINE REAGENT, CAT. NO. 5367

Reagent, Platelet Aggregation

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Epinephrine Reagent, Cat. No. 5367.

Pre-market Notification Details

Device IDK910680
510k NumberK910680
Device Name:EPINEPHRINE REAGENT, CAT. NO. 5367
ClassificationReagent, Platelet Aggregation
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 CodeGHR  
CFR Regulation Number864.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-15
Decision Date1991-05-20

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