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FDA 510(k) Application Details - K072246
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K072246
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
MAINE STANDARDS CO.
765 ROOSEVELT TRAIL
WINDHAM, ME 04062-5365 US
Other 510(k) Applications for this Company
Contact
HOLLY CRESSMAN
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2007
Decision Date
09/14/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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