DNA STAT TEST KIT

Antinuclear Antibody (enzyme-labeled), Antigen, Controls

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Dna Stat Test Kit.

Pre-market Notification Details

Device IDK843904
510k NumberK843904
Device Name:DNA STAT TEST KIT
ClassificationAntinuclear Antibody (enzyme-labeled), Antigen, Controls
Applicant WHITTAKER BIOPRODUCTS, INC. P.O. BOX 127 Walkersville ,  MD  21793 -
ContactPatricia B Shrader
CorrespondentPatricia B Shrader
WHITTAKER BIOPRODUCTS, INC. P.O. BOX 127 Walkersville ,  MD  21793 -
Product CodeLJM  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-03
Decision Date1984-11-01

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