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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 K944426
Device Name BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
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
JHI  
Date Received09/12/1994
Decision Date 10/25/1994
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
Recalls CDRH Recalls
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