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FDA 510(k) Application Details - K023194
Device Classification Name
Glucose Oxidase, Glucose
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510(K) Number
K023194
Device Name
Glucose Oxidase, Glucose
Applicant
LIFESCAN, INC.
1000 GIBRALTAR DR.
MILPITAS, CA 95035-6312 US
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Contact
JOJN E HUGHES
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
09/25/2002
Decision Date
10/24/2002
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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