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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K022769
Device Name LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION
Applicant
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01432
Applicant Contact KATHLEEN STORRO
Correspondent
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01432
Correspondent Contact KATHLEEN STORRO
Regulation Number862.1660
Classification Product Code
JJX  
Date Received08/21/2002
Decision Date 11/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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