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510(k) Data Aggregation
K Number
K062981Device Name
I-CHROMA CRP TEST
Manufacturer
Date Cleared
2007-07-13
(287 days)
Product Code
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
BODITECH DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The i-CHROMA™ CRP test along with i-CHROMA™ Reader is an in vitro diagnostic fluorescence immunoassay that measures C-Reactive Protein in whole blood and serum. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues, infection, and inflammatory disorders.
Device Description
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