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FDA 510(k) Application Details - K081360
Device Classification Name
Fluorometric Method, Cpk Or Isoenzymes
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510(K) Number
K081360
Device Name
Fluorometric Method, Cpk Or Isoenzymes
Applicant
MITSUBISHI KAGAKU IATRON
701 FIFTH AVENUE
FLOOR 42
SEATTLE, WA 98104 US
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Contact
HELEN LANDICHO
Other 510(k) Applications for this Contact
Regulation Number
862.1215
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Classification Product Code
JHX
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More FDA Info for this Product Code
Date Received
05/15/2008
Decision Date
08/17/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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