FDA 510(k)

ABX MICROS ES 60 OT 和 ABX MICROS ES 60 CT

K号: K170353 · 2017-11-01

决定日期2017-11-01

产品代码GKZ

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决定实质等同

器械摘要

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.

常见问题

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?

FDA 510(k)记录显示HORIBA ABX SAS为申请人。这本身并不能确立该设备制造商的身份。

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.

列明HORIBA ABX SAS为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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