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K Number
K000527
Device Name
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
2000-04-07

(50 days)

Product Code
GIR
Regulation Number
864.8950
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 864.8950 Russell viper venom reagent.

(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).