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FDA 510(k) Application Details - K072249
Device Classification Name
Enzymatic Esterase--Oxidase, Cholesterol
More FDA Info for this Device
510(K) Number
K072249
Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Applicant
MEDICA CORP.
163 CABOT STREET
BEVERLY, MA 01915 US
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Contact
FRAN WHITE
Other 510(k) Applications for this Contact
Regulation Number
862.1175
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Classification Product Code
CHH
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More FDA Info for this Product Code
Date Received
08/13/2007
Decision Date
02/20/2008
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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