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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K962597
Device Name LXN FRUCTOSAMINE TEST SYSTEM
Applicant
Lxn Corp.
5830 Oberlin Dr.
Suite 102
San Diego,  CA  92121
Applicant Contact VIVIANNE T NOETZEL
Correspondent
Lxn Corp.
5830 Oberlin Dr.
Suite 102
San Diego,  CA  92121
Correspondent Contact VIVIANNE T NOETZEL
Regulation Number864.7470
Classification Product Code
LCP  
Date Received07/02/1996
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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