FDA 510(k)

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

K-Nummer: K201505 · 2020-08-22

Entscheidungsdatum2020-08-22

ProduktcodeOCC

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2020-08-22 under 510(k) number K201505. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2020-08-22. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K201505.

When did Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack receive FDA 510(k) clearance?

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack received FDA 510(k) clearance on 2020-08-22, under 510(k) number K201505.

Who is the listed applicant for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

The FDA 510(k) record lists Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack?

The FDA product code for Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack is OCC.

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Weitere Einträge mit Diasorin Molecular, LLC als Antragsteller

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit K251978LIAISON NES FLU A/B, RSV & COVID-19 K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K220963Simplexa COVID-19 & Flu A/B Direct K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack K212147Simplexa COVID-19 Direct

Alle 13 Geräte anzeigen →

Verwandte Geräte (Code: OCC)

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

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