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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cannabinoid(S)
510(k) Number K833911
Device Name URINE THC CANNABINOIDS DIRECT RIA KIT
Applicant
Immunalysis Corporation
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Immunalysis Corporation
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3870
Classification Product Code
LAT  
Date Received11/14/1983
Decision Date 01/24/1984
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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