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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 K894804
Device Name SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
Applicant
Lifescan, Inc.
2443 Wyandotte St.
Mountain View,  CA  94043
Applicant Contact ROSEMARY D SELF
Correspondent
Lifescan, Inc.
2443 Wyandotte St.
Mountain View,  CA  94043
Correspondent Contact ROSEMARY D SELF
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/28/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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