FDA 510(k)

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

Numéro K : K163266 · 2016-12-21

Date de décision2016-12-21

Code produitOCC

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument 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 2016-12-21 under 510(k) number K163266. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument?

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K163266.

When did Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument receive FDA 510(k) clearance?

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument received FDA 510(k) clearance on 2016-12-21, under 510(k) number K163266.

Who is the listed applicant for Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument?

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 Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument?

The FDA product code for Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument is OCC.

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Autres dossiers indiquant Alere Scarborough, Inc. en tant que demandeur

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Source officielle

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