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FDA 510(k)

ARGOS

K-Number: K895127 · 1989-10-10

ApplicantAbx, Inc.
Decision Date1989-10-10
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ARGOS is the device name listed in this FDA 510(k) record. The listed applicant is Abx, Inc.. It received FDA 510(k) clearance on 1989-10-10 under 510(k) number K895127. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGOS?

ARGOS is a medical device that received FDA 510(k) clearance on 1989-10-10. The listed applicant is Abx, Inc.. The 510(k) number is K895127.

When did ARGOS receive FDA 510(k) clearance?

ARGOS received FDA 510(k) clearance on 1989-10-10, under 510(k) number K895127.

Who is the listed applicant for ARGOS?

The FDA 510(k) record lists Abx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGOS?

The FDA product code for ARGOS is GKZ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Abx, Inc. 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.

K962633VEGA HEMATOLOGY ANALYZERK880616MINOS AUTOMATIC CELL COUNTERK864579MINOS AUTOMATIC CELL COUNTER

Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

Official Source

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

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