VENTREX ALLERGEN DISC

System, Test, Radioallergosorbent (rast) Immunological

VENTREX, INC.

The following data is part of a premarket notification filed by Ventrex, Inc. with the FDA for Ventrex Allergen Disc.

Pre-market Notification Details

Device IDK925044
510k NumberK925044
Device Name:VENTREX ALLERGEN DISC
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant VENTREX, INC. 217 READ ST. P.O. BOX 9731 Portland,  ME  04104
ContactAnne Jepson
CorrespondentAnne Jepson
VENTREX, INC. 217 READ ST. P.O. BOX 9731 Portland,  ME  04104
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-05
Decision Date1993-05-14

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