FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES

Extractable Antinuclear Antibody, Antigen And Control

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Fiax Test Kit For Ena (rnp/sm) Antibodies.

Pre-market Notification Details

Device IDK873708
510k NumberK873708
Device Name:FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactLouise M Harris
CorrespondentLouise M Harris
WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
Product CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-15
Decision Date1987-11-25

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