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FDA 510(k)

MINOS AUTOMATIC CELL COUNTER

K-Number: K880616 · 1988-05-02

ApplicantAbx, Inc.
Decision Date1988-05-02
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MINOS AUTOMATIC CELL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Abx, Inc.. It received FDA 510(k) clearance on 1988-05-02 under 510(k) number K880616. 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 MINOS AUTOMATIC CELL COUNTER?

MINOS AUTOMATIC CELL COUNTER is a medical device that received FDA 510(k) clearance on 1988-05-02. The listed applicant is Abx, Inc.. The 510(k) number is K880616.

When did MINOS AUTOMATIC CELL COUNTER receive FDA 510(k) clearance?

MINOS AUTOMATIC CELL COUNTER received FDA 510(k) clearance on 1988-05-02, under 510(k) number K880616.

Who is the listed applicant for MINOS AUTOMATIC CELL COUNTER?

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 MINOS AUTOMATIC CELL COUNTER?

The FDA product code for MINOS AUTOMATIC CELL COUNTER 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 ANALYZERK895127ARGOSK864579MINOS 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

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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