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FDA 510(k) Application Details - K070835
Device Classification Name
Colorimetric Method, Cpk Or Isoenzymes
More FDA Info for this Device
510(K) Number
K070835
Device Name
Colorimetric Method, Cpk Or Isoenzymes
Applicant
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
LISMEEHAN
O'CALLAGHANS MILLS, CO. CLARE IE
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Contact
STEPHANIE G SCHWARTZ
Other 510(k) Applications for this Contact
Regulation Number
862.1215
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Classification Product Code
JHY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/27/2007
Decision Date
06/04/2007
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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