Substantially Equivalent 510(k) Device Information
Applicant: Boston Biomedica, Inc, West Bridgewater, MA
510(k) number: BK040067
Product: ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV)
Date: 11/19/2004
Letter -
(Text)
Summary of Safety and Effectiveness -
(PDF)
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