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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 K821982
Device Name TITAN GEL SERUM CONTROL
Applicant
HELENA LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HELENA LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/06/1982
Decision Date 08/16/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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