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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K926308
Device Name LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST
Applicant
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543 -7139
Applicant Contact JEMO KANG
Correspondent
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543 -7139
Correspondent Contact JEMO KANG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received12/15/1992
Decision Date 01/26/1993
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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