VENTREX ALLERGEN DISC

System, Test, Radioallergosorbent (rast) Immunological

VENTREX LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK913833
510k NumberK913833
Device Name:VENTREX ALLERGEN DISC
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland,  ME  04103
ContactH. W Founds
CorrespondentH. W Founds
VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland,  ME  04103
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-26
Decision Date1992-02-21

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