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K Number
K960947
Device Name
SAS SICKLE CELL TEST
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
1996-07-01

(115 days)

Product Code
GHM
Regulation Number
864.7825
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 864.7825 Sickle cell test.

(a)
Identification. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.(b)
Classification. Class II (performance standards).