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510(k) Data Aggregation
K Number
K980855Device Name
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
Manufacturer
DPC CIRRUS
Date Cleared
1998-04-21
(47 days)
Product Code
DHX
Regulation Number
866.6010Why did this record match?
Applicant Name (Manufacturer) :
DPC CIRRUS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer and designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum. It is intended for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.
Device Description
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer.
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K Number
K970227Device Name
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
Manufacturer
DPC CIRRUS
Date Cleared
1997-04-08
(81 days)
Product Code
JJE, CGJ, DHB, JHR, JLW, KLS
Regulation Number
862.2160Why did this record match?
Applicant Name (Manufacturer) :
DPC CIRRUS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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