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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Olympus PK CMV-PA Test System and Controls for the Olympus PK7300 Automated Blood Bank Analyzer

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