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FDA 510(k) Application Details - K062751
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K062751
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH, CA 90278-1205 US
Other 510(k) Applications for this Company
Contact
BERNICE NAVARRO
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2006
Decision Date
10/03/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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