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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K982217
Device Name AC/AD 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 Hwy. 8
New Brighton,  MN  55112
Correspondent Contact CAROLE STAMP
Regulation Number862.3280
Classification Product Code
DIF  
Date Received06/24/1998
Decision Date 07/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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