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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 K880674
Device Name MICROMEDIC CRACKPOT RIA KIT
Applicant
Icn Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact DEBRA L MANSFIELD
Correspondent
Icn Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact DEBRA L MANSFIELD
Regulation Number862.3250
Classification Product Code
KLN  
Date Received02/19/1988
Decision Date 10/06/1988
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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