FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG

Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fitc Murine Monoclonal Anti-hsv Bivalent Igg.

Pre-market Notification Details

Device IDK880996
510k NumberK880996
Device Name:FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
ClassificationAntigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactMarie P Reeves
CorrespondentMarie P Reeves
WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
Product CodeGQN  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-08
Decision Date1988-05-13

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