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510(k) Data Aggregation
K Number
K980757Device Name
ILAB 600 CLINICAL CHEMISTRY SYSTEM
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
1998-04-21
(53 days)
Product Code
CGZ, CEK, CEM, CFJ, CFR, CGA, CGS, CGX, CIC, CIG, CIT, CIX, CJE, CKB, DIH, JFJ, JGJ, JGS, JIX, JJW, JJX, JJY, KHS
Regulation Number
862.1170Why did this record match?
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Matched: '862.1210'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.
Device Description
The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.
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