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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 K822515
Device Name B-HCG RADIOIMMUNOASSAY KIT
Applicant
BIOCLINICAL GROUP
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOCLINICAL GROUP
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1155
Classification Product Code
JHI  
Date Received08/20/1982
Decision Date 09/14/1982
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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