Vials, Challenge, Endotoxin

Vials, Challenge, Endotoxin

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Vials, Challenge, Endotoxin.

Pre-market Notification Details

Device IDBK910010
510k NumberBK910010
Device Name:Vials, Challenge, Endotoxin
ClassificationVials, Challenge, Endotoxin
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 Biggs Ford Road Walkersville,  MO  21793
Product CodeMTS  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-12
Decision Date1991-08-09

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