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


Summary (PDF - 62 KB)

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Updated: August 21, 2008