ABL-700 Series, Model Abl 7XX (Various Models)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002290 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 Abl-700 Series, Model Abl 7Xx is an Electrode Measurement device for Blood-Gases (Pco2, Po2) and Blood Ph. It is used to measure certain gases in blood, serum, plasma, or pH of blood, serum, and plasma. This device falls under the category of Clinical Chemistry.
The device is supplied in various models and is classified under the regulation number 862.1120. It has been assigned the product code CHL and has received FDA 510(k) clearance. The device is intended for use in clinical settings and is manufactured by Radiometer Medical A/S.
Frequently asked questions
What is the ABL-700 Series used for?
The ABL-700 Series is used to measure certain gases in blood, serum, plasma, or pH of blood, serum, and plasma in clinical settings.
Is the ABL-700 Series supplied in multiple models?
Yes, the device is supplied in various models, including the Model Abl 7Xx, and is classified under the regulation number 862.1120.
What is the regulatory status of the ABL-700 Series?
The device has received FDA 510(k) clearance, indicating it is substantially equivalent to a predicate device.
What type of settings is the ABL-700 Series intended for?
The device is intended for use in clinical settings, such as hospitals or laboratories, and is manufactured by Radiometer Medical A/S.
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: ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290) — FDA 510(k ..., ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)… - FDA.report, Radiometer ABL-700 Reference manual - ManualMachine.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002290 | Class II | Active |
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Manufacturer
- Manufacturer
- Radiometer Medical A/S
Sources (1)
- FDA 510(k) K002290 24 fields · synced Sep 27, 2026