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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120013 Statement

510(k) STATEMENT

[As Required by 21 CFR 807.93]

I certify that, in my capacity as Head of Regulatory Affairs of Siemens Healthcare Diagnostics Inc., I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in this premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the Special 510(k) premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21CFR20.61.

/signature/
Robert Eusebio, Director Molecular Regulatory Affairs
Siemens Healthcare Diagnostics Inc.

/date/
(Date of Signature)