FDA 510(k)

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

K-Nummer: K161375 · 2016-08-18

Entscheidungsdatum2016-08-18

ProduktcodeOCC

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K161375. 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 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K161375.

When did Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit receive FDA 510(k) clearance?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit received FDA 510(k) clearance on 2016-08-18, under 510(k) number K161375.

Who is the listed applicant for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

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

What is the FDA product code for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

The FDA product code for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is OCC.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit Alere Scarborough, Inc. als Antragsteller

K190204ID NOW Influenza A & B 2 K181853Alere BinaxNOW Influenza A & B Karte 2, Alere Reader K173653Alere i Strep A 2, Alere i Gerät, Alere i Strep A 2 Kontrollswabentestkit K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 K173502Alere BinaxNOW Influenza A & B Karte 2, Alere Reader, Alere BinaxNOW Influenza A & B Karte 2 Kontrollswabsatz K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

Alle 10 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.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.