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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K990942
Device Name DUET II GLUCOSE CONTROL MONITORING SYSTEM
Applicant
Lxn Corp.
6325 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact NEDA RASHTI
Correspondent
Lxn Corp.
6325 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact NEDA RASHTI
Regulation Number862.1345
Classification Product Code
CGA  
Date Received03/22/1999
Decision Date 08/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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