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510(k) Data Aggregation
K Number
K974596Device Name
DIMERTEST LATEX ASSAYManufacturer
Date Cleared
1998-05-26
(168 days)
Product Code
Regulation Number
864.7320Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Dimertest Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma.
Device Description
Not Found
AI/ML Overview
The provided text describes a 510(k) clearance for the Dimertest Latex Assay but does not contain any information regarding specific acceptance criteria, study details, or performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on the regulatory clearance of the device as substantially equivalent to a predicate device.
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