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FDA 510(k) Application Details - K060345
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K060345
Device Name
Glucose Oxidase, Glucose
Applicant
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM, MA 02454-9141 US
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Contact
PAUL W MACDONALD
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CGA
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More FDA Info for this Product Code
Date Received
02/10/2006
Decision Date
04/28/2006
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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