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FDA 510(k)

FRESENIUS AS 104 CELL SEPARATOR

K-Number: K895435 · 1990-11-02

ApplicantFresenius USA, Inc.
Decision Date1990-11-02
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

FRESENIUS AS 104 CELL SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1990-11-02 under 510(k) number K895435. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS AS 104 CELL SEPARATOR?

FRESENIUS AS 104 CELL SEPARATOR is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K895435.

When did FRESENIUS AS 104 CELL SEPARATOR receive FDA 510(k) clearance?

FRESENIUS AS 104 CELL SEPARATOR received FDA 510(k) clearance on 1990-11-02, under 510(k) number K895435.

Who is the listed applicant for FRESENIUS AS 104 CELL SEPARATOR?

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

What is the FDA product code for FRESENIUS AS 104 CELL SEPARATOR?

The FDA product code for FRESENIUS AS 104 CELL SEPARATOR is LKN.

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Other records listing Fresenius USA, Inc. 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.

K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TSK970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXK974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSK973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61K9614652008H ON LINE CLEARANCE MONITORK961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR

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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.

K192150AMICUS Separator SystemFresenius Kabi AGK183081Spectra 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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