FDA 510(k) Application Details - K051111

Device Classification Name Bathophenanthroline, Iron Binding Capacity

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510(K) Number K051111
Device Name Bathophenanthroline, Iron Binding Capacity
Applicant SENTINEL CH. SRL
5 VIA PRINCIPE EUGENIO
MILANO 20155 IT
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Contact DAVIDE SPADA
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Regulation Number 862.1415

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Classification Product Code JQF
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Date Received 05/02/2005
Decision Date 11/17/2005
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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