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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Methaqualone
510(k) Number K830461
Device Name ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
Applicant
Hoffmann-La Roche, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hoffmann-La Roche, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3630
Classification Product Code
KXS  
Date Received02/15/1983
Decision Date 03/24/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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