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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Tricyclic Antidepressant Drugs
510(k) Number K980249
Device Name ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
Applicant
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Applicant Contact JEMO KANG
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Correspondent Contact JEMO KANG
Regulation Number862.3910
Classification Product Code
LFG  
Date Received01/23/1998
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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