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FDA 510(k) Application Details - K152117
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K152117
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
Quantimetrix Corporation
2005 Manhattan Beach Blvd
Redondo Beach, CA 90278 US
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Contact
Kaylna Snylyk
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/30/2015
Decision Date
04/21/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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