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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cocaine Metabolite
510(k) Number K871549
Device Name RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
Applicant
Immunalysis Corporation
1707 Gardena Ave.
Glendale,  CA  91204
Applicant Contact SOARES, PHD
Correspondent
Immunalysis Corporation
1707 Gardena Ave.
Glendale,  CA  91204
Correspondent Contact SOARES, PHD
Regulation Number862.3250
Classification Product Code
KLN  
Date Received04/14/1987
Decision Date 06/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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