FDA 510(k)

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

Numéro K : K190298 · 2019-10-04

DemandeurBeckman Coulter Biomedical GmbH

Date de décision2019-10-04

Code produitCDD

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Biomedical GmbH. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190298. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Beckman Coulter Biomedical GmbH. The 510(k) number is K190298.

When did DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 receive FDA 510(k) clearance?

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190298.

Who is the listed applicant for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

The FDA 510(k) record lists Beckman Coulter Biomedical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

The FDA product code for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is CDD.

Essais cliniques associés

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Dispositifs connexes (Code : CDD)

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamine B12Beckman Coulter, Inc.K192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) EssaiAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Essai, Contrôle de Qualité ADVIA Centaur Active-B12(AB12) et Matériaux de Courbe Master (MCM) ADVIA Centaur Active-B12 (AB12)Axis-Shield Diagnostics Limited

Source officielle

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