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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
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