FDA 510(k) Application Details - K132249

Device Classification Name Radioimmunoassay, Free Thyroxine

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510(K) Number K132249
Device Name Radioimmunoassay, Free Thyroxine
Applicant Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact MATTEW GEE
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Regulation Number 862.1695

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Classification Product Code CEC
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Date Received 07/19/2013
Decision Date 09/13/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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