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FDA 510(k) Application Details - DEN060007
Device Classification Name
Quality Control Material, Genetics, Dna
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
866.5910
More FDA Info for this Regulation Number
Classification Product Code
NZB
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More FDA Info for this Product Code
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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