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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Alsever’s Solution (510(k) exempt but part of system)

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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