3M IGE SINGLE POINT FAST TEST

System, Test, Radioallergosorbent (rast) Immunological

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for 3m Ige Single Point Fast Test.

Pre-market Notification Details

Device IDK913212
510k NumberK913212
Device Name:3M IGE SINGLE POINT FAST TEST
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactSylvia Zorich
CorrespondentSylvia Zorich
WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-19
Decision Date1991-11-22

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