Substantially Equivalent 510(k) Device Information

Applicant:   Fujirebio Diagnostics, Inc, Malvern, PA 19355
510(k) number:   BK030007
Product:   Olympus PK TP System
Date:   2/21/2003


Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.

Letter

Statement (PDF - 88 KB)

Label (PDF - 254 KB)

 
Updated: February 26, 2008