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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K884269
Device Name SAMPLE IDENTIFICATION STATION MODEL 38010
Applicant
Icn Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Icn Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received10/11/1988
Decision Date 01/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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