FDA 510(k) Application Details - DEN060007

Device Classification Name Quality Control Material, Genetics, Dna

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510(K) Number DEN060007
Device Name Quality Control Material, Genetics, Dna
Applicant MAINE MOLECULAR QUALITY CONTROLS, INC.
10 Southgate Road
Scarborough, ME 04074 US
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Contact JOAN GORDON
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Regulation Number 866.5910

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Classification Product Code NZB
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Date Received 08/14/2006
Decision Date 10/12/2006
Decision DENG -
Classification Advisory Committee MI - Microbiology
Review Advisory Committee PA - Pathology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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