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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 K945514
Device Name LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
Applicant
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852 -1905
Applicant Contact JEMO KANG
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852 -1905
Correspondent Contact JEMO KANG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/09/1994
Decision Date 02/10/1995
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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