FDA 510(k) Application Details - K140842

Device Classification Name Radioimmunoassay, Free Thyroxine

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510(K) Number K140842
Device Name Radioimmunoassay, Free Thyroxine
Applicant Siemens Healthcare Diagnostics Inc.
PO BOX 6101
M/S 514
NEWARK, DE 19714-6101 US
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Contact FRANCES A DILLON
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Regulation Number 862.1695

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Classification Product Code CEC
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Date Received 04/02/2014
Decision Date 11/26/2014
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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