STAT TEST KIT FOR EB-VCA IGG ANTIBODY

Epstein-barr Virus, Other

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Stat Test Kit For Eb-vca Igg Antibody.

Pre-market Notification Details

Device IDK891086
510k NumberK891086
Device Name:STAT TEST KIT FOR EB-VCA IGG ANTIBODY
ClassificationEpstein-barr Virus, Other
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 CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-01
Decision Date1989-05-10

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