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FDA 510(k)

AMICUS Separator System

K-Number: K192150 · 2019-11-13

ApplicantFresenius Kabi AG
Decision Date2019-11-13
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

AMICUS Separator System is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2019-11-13 under 510(k) number K192150. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICUS Separator System?

AMICUS Separator System is a medical device that received FDA 510(k) clearance on 2019-11-13. The listed applicant is Fresenius Kabi AG. The 510(k) number is K192150.

When did AMICUS Separator System receive FDA 510(k) clearance?

AMICUS Separator System received FDA 510(k) clearance on 2019-11-13, under 510(k) number K192150.

Who is the listed applicant for AMICUS Separator System?

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

What is the FDA product code for AMICUS Separator System?

The FDA product code for AMICUS Separator System is LKN.

Other records listing Fresenius Kabi AG 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.

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Related Devices (Code: LKN)

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.

K183081Spectra Optia Apheresis SystemTerumobct, Inc.K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,LlcK181049Spectra Optia Apheresis SystemTerumobct, Inc.K172590Spectra Optia Apheresis SystemTerumobct, Inc.K153601Spectra Optia Apheresis SystemTerumobct, 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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