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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 K822698
Device Name GLUCOSCAN CONTROLS
Applicant
LIFESCAN, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
LIFESCAN, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1660
Classification Product Code
JJX  
Date Received09/07/1982
Decision Date 09/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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