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FDA 510(k)

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

K-Number: K002290 · 2000-09-13

ApplicantRadiometer Medical A/S
Decision Date2000-09-13
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical A/S. It received FDA 510(k) clearance on 2000-09-13 under 510(k) number K002290. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)?

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) is a medical device that received FDA 510(k) clearance on 2000-09-13. The listed applicant is Radiometer Medical A/S. The 510(k) number is K002290.

When did ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) receive FDA 510(k) clearance?

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) received FDA 510(k) clearance on 2000-09-13, under 510(k) number K002290.

Who is the listed applicant for ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)?

The FDA 510(k) record lists Radiometer Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)?

The FDA product code for ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) is CHL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Radiometer Medical A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001866TCM400

Related Devices (Code: CHL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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