Search Results
Found 2 results
510(k) Data Aggregation
K Number
K970905Device Name
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
Manufacturer
BECKMAN INSTRUMENTS, INC.
Date Cleared
1997-06-04
(84 days)
Product Code
CHI, JIT
Regulation Number
862.1465Why did this record match?
Product Code :
CHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYNCHRON® Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
Device Description
This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® AND LX™ Clinical Systems. The SYNCHRON Systems Lipase (LIPA) Reagent, when used in coniunction with SYCNRHON Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Ask a Question
K Number
K961179Device Name
SENTINEL LIPASE LIQUID MODEL 17.401B
Manufacturer
EQUAL DIAGNOSTICS, INC.
Date Cleared
1996-07-19
(115 days)
Product Code
CHI
Regulation Number
862.1465Why did this record match?
Product Code :
CHI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1