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FDA 510(k)

ABL837 FLEX ANALYZER

K-Number: K100777 · 2010-12-10

ApplicantRadiometer Medical Aps
Decision Date2010-12-10
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABL837 FLEX ANALYZER 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 2010-12-10 under 510(k) number K100777. 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 ABL837 FLEX ANALYZER?

ABL837 FLEX ANALYZER is a medical device that received FDA 510(k) clearance on 2010-12-10. The listed applicant is Radiometer Medical Aps. The 510(k) number is K100777.

When did ABL837 FLEX ANALYZER receive FDA 510(k) clearance?

ABL837 FLEX ANALYZER received FDA 510(k) clearance on 2010-12-10, under 510(k) number K100777.

Who is the listed applicant for ABL837 FLEX ANALYZER?

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 ABL837 FLEX ANALYZER?

The FDA product code for ABL837 FLEX ANALYZER is CHL.

Related Clinical Trials

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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: 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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