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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K791706
Device Name BE-SURE
Applicant
Precision Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Precision Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received08/17/1979
Decision Date 10/17/1979
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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