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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 K131479
Device Name V8 SP NORMAL CONTROL, ABNORMAL CONTROL
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
BEAUMONT,  TX  77704
Applicant Contact JUSTIN PADIA
Correspondent
HELENA LABORATORIES
1530 LINDBERGH DR.
BEAUMONT,  TX  77704
Correspondent Contact JUSTIN PADIA
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/22/2013
Decision Date 10/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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