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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K811912
Device Name HELENA VMA-SMC 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
JJX  
Date Received07/01/1981
Decision Date 07/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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