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)