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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
Predetermined Change
Control Plan Authorized		 No
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