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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Amphetamine
510(k) Number K913866
Device Name URINE AMPHETAMINE DIRECT RIA KIT (I-125)
Applicant
Immunalysis Corporation
1707 Gardena Ave.
Glendale,  CA  91204
Applicant Contact JAMES R SOARES
Correspondent
Immunalysis Corporation
1707 Gardena Ave.
Glendale,  CA  91204
Correspondent Contact JAMES R SOARES
Regulation Number862.3100
Classification Product Code
DJP  
Date Received08/27/1991
Decision Date 09/25/1991
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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