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ABL300 Acid Base Laboratory

FDA 510(k)

Class II (US FDA 510(k))

510(k) K844295

by Radiometer America, Inc.

Identifiers

510(k) Number
K844295 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 ABL300 Acid Base Laboratory is an electrode measurement device for blood gases (Pco2, Po2) and blood pH, classified under device type Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph. It is a substantially equivalent device cleared via the traditional 510(k) pathway under product code CHL and regulation number 862.1120.

Manufactured by Radiometer America, Inc., the device received FDA 510(k) clearance K844295 on December 10, 1984. It is intended for use in clinical chemistry settings to measure blood gases and pH in blood, serum, or plasma, supporting the diagnosis and treatment of acid-base disturbances.

Frequently asked questions

What is the ABL300 Acid Base Laboratory intended to measure?

The ABL300 Acid Base Laboratory is intended to measure blood gases (Pco2, Po2) and blood pH in blood, serum, or plasma, supporting the diagnosis and treatment of acid-base disturbances in clinical chemistry settings.

How was the ABL300 Acid Base Laboratory cleared for marketing in the United States?

The ABL300 Acid Base Laboratory received FDA 510(k) clearance via the traditional pathway under K844295 on December 10, 1984, as a substantially equivalent device to a legally marketed predicate.

What regulatory classification and product code apply to the ABL300 Acid Base Laboratory?

The ABL300 Acid Base Laboratory is classified as a Class II device under product code CHL and regulation number 862.1120, which covers electrode measurement devices for blood gases and blood pH.

Who manufactures the ABL300 Acid Base Laboratory and where is it located?

The ABL300 Acid Base Laboratory is manufactured by Radiometer America, Inc., located at 811 Sharon Dr., Westlake, OH 44145, United States.

What type of device is the ABL300 Acid Base Laboratory according to its device classification?

The ABL300 Acid Base Laboratory is an electrode measurement device specifically designed for measuring blood gases (Pco2, Po2) and blood pH, falling under the device type 'Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph'.

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: ABL300 ACID BASE LABORATORY (K844295) — FDA 510(k) | Innolitics, PDF K844295 - ABL300 ACID BASE LABORATORY - 510kdatabase.net, Radiometer America… — 50 FDA 510 (k)s · DeviceClearance, fda.innolitics.com, Parameters measured on ABL blood gas analyzers - Radiometer

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) K844295 24 fields · synced Sep 19, 2026