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FDA 510(k) Application Details - K100187
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K100187
Device Name
Glucose Oxidase, Glucose
Applicant
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD, MA 01730 US
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Contact
Photios Makris
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CGA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/22/2010
Decision Date
05/05/2010
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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