MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI

Chromatographic Separation, Cpk Isoenzymes

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Modification To Cardiac Status Ck-mb/myoglobin Rapid One-step Test, Lifesign Mi Ck-mb/myoglobin, Lifesign Ck-mb/myoglobi.

Pre-market Notification Details

Device IDK991299
510k NumberK991299
Device Name:MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
ClassificationChromatographic Separation, Cpk Isoenzymes
Applicant PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
ContactJemo Kang
CorrespondentJemo Kang
PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
Product CodeJHT  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-06
Decision Date1999-05-28

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