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FDA 510(k) Application Details - K002134
Device Classification Name
Glucose Oxidase, Glucose
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510(K) Number
K002134
Device Name
Glucose Oxidase, Glucose
Applicant
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM, MA 02154-3457 US
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CAROL A ADILETTO, M.S.
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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
07/14/2000
Decision Date
08/07/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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