FDA 510(k)

ABX MICROS CRP 200, OPTION IM

K-Number: K053308 · 2005-12-29

Decision Date2005-12-29

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ABX MICROS CRP 200, OPTION IM is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2005-12-29 under 510(k) number K053308. 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 CRP 200, OPTION IM?

ABX MICROS CRP 200, OPTION IM is a medical device that received FDA 510(k) clearance on 2005-12-29. The listed applicant is Horiba Abx. The 510(k) number is K053308.

When did ABX MICROS CRP 200, OPTION IM receive FDA 510(k) clearance?

ABX MICROS CRP 200, OPTION IM received FDA 510(k) clearance on 2005-12-29, under 510(k) number K053308.

Who is the listed applicant for ABX MICROS CRP 200, OPTION IM?

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

What is the FDA product code for ABX MICROS CRP 200, OPTION IM?

The FDA product code for ABX MICROS CRP 200, OPTION IM is GKZ.

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Other records listing Horiba Abx as applicant

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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.