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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 K821657
Device Name RIAGEN B-HCG RIA
Applicant
Biogenex Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biogenex Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1155
Classification Product Code
JHI  
Date Received06/04/1982
Decision Date 07/13/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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