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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 K013342
Device Name EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
Applicant
Chay Medical, LLC
3257 Route 128
Calistoga,  CA  94515
Applicant Contact STEPHEN C PEARSON
Correspondent
Chay Medical, LLC
3257 Route 128
Calistoga,  CA  94515
Correspondent Contact STEPHEN C PEARSON
Regulation Number862.1345
Classification Product Code
CGA  
Date Received10/09/2001
Decision Date 02/15/2002
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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