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ABL555 Blood Gas, Electrolyte & Metabolite System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K973367

by Radiometer America, Inc.

Identifiers

510(k) Number
K973367 FDA 510(k)
FDA Product Code
CHL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1120 FDA 510(k)
Regulation Number
862.1120 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ABL555 is a standalone blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2, Na+, K+, and glucose on whole blood. It is designed to assess acid-base balance, electrolyte status, and metabolic parameters to facilitate clinical decision-making in acute care or laboratory environments.

The ABL555 Blood Gas, Electrolyte & Metabolite System is an automated analyzer with dimensions of 40 cm x 55 cm x 40 cm and a weight of 37.5 kg. It is a Class 2 device with FDA 510(k) clearance (K973367) under product code CHL, classified as an Electrode Measurement, Blood-gases (pCO2, pO2) and Blood Ph device, and regulated under number 862.1120.

Frequently asked questions

What is the ABL555 Blood Gas, Electrolyte & Metabolite System used for?

The ABL555 is a standalone analyzer designed to measure pH, pCO2, pO2, Na+, K+, and glucose on whole blood. It helps assess acid-base balance, electrolyte status, and metabolic parameters to facilitate clinical decision-making in acute care or laboratory environments.

What are the dimensions and weight of the ABL555 analyzer?

The ABL555 analyzer has dimensions of 40 cm x 55 cm x 40 cm and weighs 37.5 kg. It is designed to fit in laboratory and acute care settings while providing comprehensive blood gas and electrolyte analysis capabilities.

What regulatory status does the ABL555 have?

The ABL555 is a Class 2 device with FDA 510(k) clearance (K973367) under product code CHL, classified as an Electrode Measurement, Blood-gases (pCO2, pO2) and Blood Ph device, and regulated under number 862.1120.

What measurements can the ABL555 analyzer perform?

The ABL555 analyzer can measure pH, pCO2, pO2, Na+, K+, and glucose on whole blood samples. These measurements help clinicians assess acid-base balance, electrolyte status, and metabolic parameters for patient evaluation and treatment decisions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Abl555 Blood Gas, Electrolyte & Metabolite System, Abl555 Blood Gas, Electrolyte & Metabolite System (K974818) — Fda 510 ..., ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Radiometer America, Inc.

Sources (1)

  • FDA 510(k) K973367 24 fields · synced Sep 22, 2026