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510(k) Data Aggregation
K Number
K011720Device Name
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
2001-06-25
(21 days)
Product Code
CIX, CDO, CDQ, CDT, CEK, CEM, CEO, CFJ, CFQ, CFR, CGS, CGX, CGZ, CHH, CHS, CIC, CIG, CIT, CJE, CKA, CZW, DAD, DBF, DBI, DCN, DDD, DDR, DDS, DEM, DHR, GTQ, JFJ, JGJ, JGS, JHH, JHN, JIR, JIY, JJE, JLB, JMO, JQB, JZG, LBS, LKL
Regulation Number
862.1035Why did this record match?
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Matched: '866.5420'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
Device Description
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.
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K Number
K964257Device Name
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
Manufacturer
BECKMAN INSTRUMENTS, INC.
Date Cleared
1997-03-24
(150 days)
Product Code
LKL
Regulation Number
866.5420Why did this record match?
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Matched: '866.5420'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMMAGE Immunochemistry System Alpha - Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-acid glycoprotein by rate nephelometry.
Device Description
The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.
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