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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Antimycobacteria, Susceptibility Test
510(k) Number K840981
Device Name NIACIN REAGENT STRIP
Applicant
Remel Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Remel Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.1700
Classification Product Code
MJD  
Date Received03/06/1984
Decision Date 03/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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