Substantially Equivalent 510(k) Device Information

Applicant:   Fujirebio Diagnostics, Inc, Malvern, PA
510(k) number:   BK070030
Product:   Olympus PK CMV-PA Test System and Controls for the Olympus PK7300 Automated Blood Bank Analyzer
Date:   9/20/2007


Letter

Package Insert (PDF - 521 KB)

 
Updated: September 26, 2007