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K Number
K001043

Validate with FDA (Live)

Device Name
KAWASUMI LABORATORY BLOOD DRAWING KIT
Manufacturer
KAWASUMI LABORATORIES AMERICA, INC.
Date Cleared
2000-05-19

(49 days)

Product Code
KSB
Regulation Number
864.9875
Type
Traditional
Panel
Hematology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K073257,K172957
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 864.9875 Transfer set.

(a)
Identification. A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to transfer blood or plasma from one container to another.(b)
Classification. Class II (performance standards).