FDA 510(k)

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

K-Number: K170353 · 2017-11-01

Decision Date2017-11-01

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2017-11-01 under 510(k) number K170353. 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 ABX MICROS ES 60 OT and ABX MICROS ES 60 CT?

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT is a medical device that received FDA 510(k) clearance on 2017-11-01. The listed applicant is HORIBA ABX SAS. The 510(k) number is K170353.

When did ABX MICROS ES 60 OT and ABX MICROS ES 60 CT receive FDA 510(k) clearance?

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT received FDA 510(k) clearance on 2017-11-01, under 510(k) number K170353.

Who is the listed applicant for ABX MICROS ES 60 OT and ABX MICROS ES 60 CT?

The FDA 510(k) record lists HORIBA ABX SAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABX MICROS ES 60 OT and ABX MICROS ES 60 CT?

The FDA product code for ABX MICROS ES 60 OT and ABX MICROS ES 60 CT is GKZ.

Other records listing HORIBA ABX SAS 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.

K232946Yumizen H2500 K193649Yumizen C1200 Creatinine PAP K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M K192028Yumizen C1200 CRP K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor K191993Yumizen C1200 CRP

View all 9 devices →

Related Devices (Code: GKZ)

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories

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.