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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K972976
Device Name CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
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
JJT  
Date Received08/11/1997
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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