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FDA 510(k) Application Details - K052207
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K052207
Device Name
Glucose Oxidase, Glucose
Applicant
INCLINE MEDICAL, LLC
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact
GREG HOLLAND
Other 510(k) Applications for this Contact
Regulation Number
862.1345
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Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
08/12/2005
Decision Date
03/09/2006
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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