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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K892654
Device Name BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST
Applicant
Princeton Biomedix
24 B Worlds Fair Dr.
Somerset,  NJ  08873
Applicant Contact KANG, PH.D.
Correspondent
Princeton Biomedix
24 B Worlds Fair Dr.
Somerset,  NJ  08873
Correspondent Contact KANG, PH.D.
Regulation Number862.1155
Classification Product Code
DHA  
Date Received04/13/1989
Decision Date 06/19/1989
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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