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K Number
K955561
Device Name
BUHLMANN VITAMIN B6 REA
Manufacturer
AMERICAN LABORATORY PRODUCTS CO., LTD.
Date Cleared
1996-05-23

(169 days)

Product Code
CDD,JIT,JJX
Regulation Number
862.1810
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.1810 Vitamin B

12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.