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FDA 510(k) Application Details - K113269
Device Classification Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K113269
Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
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
862.1050
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Classification Product Code
CJE
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More FDA Info for this Product Code
Date Received
11/04/2011
Decision Date
12/29/2011
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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