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510(k) Data Aggregation
K Number
K050790Device Name
SPOTCHEM II LDH TEST
Manufacturer
ARKRAY, INC.
Date Cleared
2005-06-06
(70 days)
Product Code
CFH
Regulation Number
862.1440Why did this record match?
Product Code :
CFH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPOTCHEM II LDH test is intended to measure the activity of the enzyme lactate dehydrogenase in serum, plasma, and whole blood. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
Device Description
Not Found
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K Number
K020484Device Name
CARESIDE LDH
Manufacturer
CARESIDE, INC.
Date Cleared
2002-07-03
(140 days)
Product Code
CFH
Regulation Number
862.1440Why did this record match?
Product Code :
CFH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use with the CARESIDE Analyzer to measure LDH activity from anti-coagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with certain liver diseases, heart diseases, and tumors of the lung, kidneys, and liver.
Device Description
CARESIDE LDH cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure LDH activity in anti-coagulated whole blood, serum or plasma specimens. The CARESIDE LDH cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of LDH activity. The patented film cartridge contains all reagents necessary to measure LDH activity.
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