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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
510(k) Number K881102
Device Name MICROMEDIC MORPHINE 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 Number862.3640
Classification Product Code
DOE  
Date Received03/15/1988
Decision Date 06/24/1988
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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