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FDA 510(k)

ABL90 FLEX SERIES

K-Number: K092686 · 2010-08-06

ApplicantRadiometer Medical Aps
Decision Date2010-08-06
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL90 FLEX SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2010-08-06 under 510(k) number K092686. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABL90 FLEX SERIES?

ABL90 FLEX SERIES is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Radiometer Medical Aps. The 510(k) number is K092686.

When did ABL90 FLEX SERIES receive FDA 510(k) clearance?

ABL90 FLEX SERIES received FDA 510(k) clearance on 2010-08-06, under 510(k) number K092686.

Who is the listed applicant for ABL90 FLEX SERIES?

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

What is the FDA product code for ABL90 FLEX SERIES?

The FDA product code for ABL90 FLEX SERIES is CEM.

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Other records listing Radiometer Medical Aps 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.

K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXK170882ABL90 FLEX, ABL90 FLEX PLUSK160153ABL90 FLEX PLUSK131988ABL90 FLEX ANALYZERK130144ABL90 FLEXK123748ABL90 FLEX

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Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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