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FDA 510(k) Application Details - K093737
Device Classification Name
Quality Control Material, Genetics, Dna
More FDA Info for this Device
510(K) Number
K093737
Device Name
Quality Control Material, Genetics, Dna
Applicant
INSTRUMENTATION LABORATORY CO.
180 BEDFORD ROAD
BEDFORD, MA 01730 US
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Contact
CAROL MARBLE
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
12/04/2009
Decision Date
05/04/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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