LogoFDA 510(k) Search
K Number
K991108
Device Name
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
Manufacturer
A.P. TOTAL CARE, INC.
Date Cleared
1999-05-25

(54 days)

Product Code
KHS
Regulation Number
862.1160
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The carbon dioxide reagent (CO2), product No. CO107-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of CO2 inserum or plasma.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a Carbon Dioxide reagent. It grants clearance for marketing but does not contain information about acceptance criteria or a study proving the device meets them. This document is a regulatory approval and not a performance study report. Therefore, I cannot extract the requested information from this text.

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.