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FDA 510(k) Application Details - K024014
Device Classification Name
Glucose Oxidase, Glucose
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510(K) Number
K024014
Device Name
Glucose Oxidase, Glucose
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY GB
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Contact
LYNNE HAMILTON
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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
12/04/2002
Decision Date
12/04/2003
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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