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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 K841854
Device Name BHCG RIA
Applicant
SYNCOR INTL. CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SYNCOR INTL. CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1155
Classification Product Code
JHI  
Date Received05/03/1984
Decision Date 06/22/1984
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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