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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 K901011
Device Name BIOSIGN HCG-ONE STEP 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
JHI  
Date Received03/05/1990
Decision Date 05/04/1990
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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