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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 K973790
Device Name ABC LINEARITY VERIFIERS
Applicant
Sc Calibrators & Controls, LLC
1701 Berkeley St.
Santa Monica,  CA  90404
Applicant Contact ROY F SCHALL JR.
Correspondent
Tuv Product Service, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/06/1997
Decision Date 10/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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