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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
510(k) Number K790986
Device Name RF CONTROLS
Applicant
Wampole Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Wampole Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3240
Classification Product Code
DMR  
Date Received05/25/1979
Decision Date 06/28/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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