FDA 510(k) Application Details - K001780

Device Classification Name Culture Media, Non-Propagating Transport

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510(K) Number K001780
Device Name Culture Media, Non-Propagating Transport
Applicant COPAN DIAGNOSTICS, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 866.2390

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Classification Product Code JSM
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Date Received 06/13/2000
Decision Date 07/31/2001
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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