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FDA 510(k)

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT

K-Number: K170353 · 2017-11-01

ApplicantHORIBA ABX SAS
Decision Date2017-11-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2017-11-01 under approval 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. It is manufactured by HORIBA ABX SAS. The 510(k) number is K170353.

When was ABX MICROS ES 60 OT and ABX MICROS ES 60 CT approved by the FDA?

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

What company makes ABX MICROS ES 60 OT and ABX MICROS ES 60 CT?

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT is manufactured by HORIBA ABX SAS.

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.

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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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