VENTREX COATED TUBE IGE RADIOIMMUNOASSAY

Ige, Antigen, Antiserum, Control

VENTREX LABORATORIES, INC.

The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrex Coated Tube Ige Radioimmunoassay.

Pre-market Notification Details

Device IDK905612
510k NumberK905612
Device Name:VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
ClassificationIge, Antigen, Antiserum, Control
Applicant VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland,  ME  04103
ContactJames W Champlin
CorrespondentJames W Champlin
VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland,  ME  04103
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-14
Decision Date1991-02-21

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