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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 K050125
Device Name RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
Applicant
More Diagnostics
2020 11th St.
Los Osos,  CA  93402
Applicant Contact JAMES W SNIPES
Correspondent
More Diagnostics
2020 11th St.
Los Osos,  CA  93402
Correspondent Contact JAMES W SNIPES
Regulation Number862.1660
Classification Product Code
JJY  
Date Received01/19/2005
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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