MURINE MONOCLONAL ANTI-ADENOVIRUS IGG

Antisera, Fluorescent, Adenovirus 1-33

WHITTAKER BIOPRODUCTS, INC.

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

Pre-market Notification Details

Device IDK885310
510k NumberK885310
Device Name:MURINE MONOCLONAL ANTI-ADENOVIRUS IGG
ClassificationAntisera, Fluorescent, Adenovirus 1-33
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactLeif E Olsen
CorrespondentLeif E Olsen
WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
Product CodeGNY  
CFR Regulation Number866.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-29
Decision Date1989-02-16

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