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FDA 510(k) Applications for Medical Device Product Code "PDE"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K140686
THE BINDING SITE GROUP LTD
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
08/06/2014
K152389
THE BINDING SITE GROUP LTD
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
12/18/2015
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