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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K963513
Device Name CARDIAC STATUS TROPONIN I
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 Number862.1215
Classification Product Code
MMI  
Date Received09/03/1996
Decision Date 11/07/1996
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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