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510(k) Data Aggregation

K Number

Device Name

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

Manufacturer

SIGMA DIAGNOSTICS, INC.

Date Cleared

2001-03-15

(148 days)

Product Code

Regulation Number

Type

Panel

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N/A

Why did this record match?

Device Name :

SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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