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FDA 510(k) Application Details - K001092
Device Classification Name
Glucose Oxidase, Glucose
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510(K) Number
K001092
Device Name
Glucose Oxidase, Glucose
Applicant
INBIOS INTL., INC.
562 1ST. AVE. SOUTH, SUITE 600
SEATTLE, WA 98104 US
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Contact
ESTELA I RAYCHAUDHURI
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
04/04/2000
Decision Date
07/26/2000
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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