Substantially Equivalent 510(k) Device Information
Applicant: Biotest Medical Diagnostics GmbH
510(k) number: BK080013
Product: Alsever’s Solution (510(k) exempt but part of system)
Solidscreen II Control B
Solidscreen Negative Control
Tango Optimo Automated Blood Bank Analyzer System with version 3.1
Date: 7/23/2008
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