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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 K981882
Device Name CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
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  
Subsequent Product Code
DEA  
Date Received05/28/1998
Decision Date 07/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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