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FDA 510(k) Application Details - K111996
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K111996
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
ELITECHGROUP
21720 23RD DR SE
SUITE 150
BOTHELL, WA 98021 US
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Contact
DEBRA K HUTSON
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
07/13/2011
Decision Date
09/14/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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