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510(k) Data Aggregation
K Number
K022409Device Name
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
Manufacturer
SPECTRAL DIAGNOSTICS, INC.
Date Cleared
2002-09-30
(68 days)
Product Code
JHT
Regulation Number
862.1215Why did this record match?
Product Code :
JHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.
Device Description
Not Found
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K Number
K991299Device Name
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1999-05-28
(52 days)
Product Code
JHT, DDR
Regulation Number
862.1215Why did this record match?
Product Code :
JHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.
Device Description
Not Found
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