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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K871537
Device Name CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II
Applicant
Canyon Diagnostics, Inc.
4081 E. La Palma Ave., Unit F
Anaheim,  CA  92807
Applicant Contact FALKOWSKI
Correspondent
Canyon Diagnostics, Inc.
4081 E. La Palma Ave., Unit F
Anaheim,  CA  92807
Correspondent Contact FALKOWSKI
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/20/1987
Decision Date 05/06/1987
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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