FDA 510(k) Application Details - K131536

Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)

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510(K) Number K131536
Device Name Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact Garo Mimaryan
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Regulation Number 862.1660

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Classification Product Code JJX
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Date Received 05/29/2013
Decision Date 08/12/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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