FDA 510(k)

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20

Numéro K : K193508 · 2020-12-04

DemandeurOxoid Limited (Part of Thermo Fisher Scientific)

Date de décision2020-12-04

Code produitJTN

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2020-12-04 under 510(k) number K193508. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20?

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 is a medical device that received FDA 510(k) clearance on 2020-12-04. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K193508.

When did Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 received FDA 510(k) clearance on 2020-12-04, under 510(k) number K193508.

Who is the listed applicant for Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20?

The FDA 510(k) record lists Oxoid Limited (Part of Thermo Fisher Scientific) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20?

The FDA product code for Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 is JTN.

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Autres dossiers indiquant Oxoid Limited (Part of Thermo Fisher Scientific) en tant que demandeur

K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 K232276Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 K203336Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 K210873Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 K203700Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

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Dispositifs connexes (Code : JTN)

K262113HardyDisk AST Tebipenem 10µg (TBP10)Hardy Diagnostics K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics K251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics

Source officielle

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