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FDA 510(k) Application Details - K143573
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K143573
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD, CA 92008 US
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Contact
Robert Burda
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
12/17/2014
Decision Date
01/16/2015
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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