Substantially Equivalent 510(k) Device Information
Applicant: GTI, INC, Waukesha, WI 53186
510(k) number: BK040035
Product: Lifecodes ID Class I: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class I molecules - Lifecodes ID Class II: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class II molecules
Date: 7/16/2004
Letter -
(Text)
Summary -
(PDF)
|