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FDA 510(k) Application Details - K101427
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K101427
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
AALTO SCIENTIFIC LTD.
1959 KELLOGG AVE.
CARLSBAD, CA 92008 US
Other 510(k) Applications for this Company
Contact
DESSI LYAKOV
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
05/21/2010
Decision Date
12/23/2010
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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