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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K881005
Device Name IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
Applicant
Icn Biomedicals, Inc.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Applicant Contact BURNS, PHD
Correspondent
Icn Biomedicals, Inc.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Correspondent Contact BURNS, PHD
Regulation Number862.1155
Classification Product Code
JHI  
Date Received03/09/1988
Decision Date 05/27/1988
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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