FDA 510(k) Application Details - K142094

Device Classification Name Culture Media, Non-Propagating Transport

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510(K) Number K142094
Device Name Culture Media, Non-Propagating Transport
Applicant COPAN ITALIA S.P.A.
62 FOREST STREE, SUITE 300
MARLBOROUGH, MA 01752 US
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Contact TINA WU
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Regulation Number 866.2390

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Classification Product Code JSM
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Date Received 08/01/2014
Decision Date 04/10/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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