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FDA 510(k) Application Details - K973140
Device Classification Name
Glucose Oxidase, Glucose
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510(K) Number
K973140
Device Name
Glucose Oxidase, Glucose
Applicant
LXN CORP.
5830 OBERLIN DR.
SUITE 102
SAN DIEGO, CA 92121 US
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Contact
VIVIANNE T NOETZEL
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
08/21/1997
Decision Date
10/31/1997
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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