FDA 510(k)

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit

Numéro K : K173653 · 2018-05-02

Date de décision2018-05-02

Code produitPGX

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 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 2018-05-02 under 510(k) number K173653. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit?

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K173653.

When did Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit receive FDA 510(k) clearance?

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit received FDA 510(k) clearance on 2018-05-02, under 510(k) number K173653.

Who is the listed applicant for Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 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 Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit?

The FDA product code for Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is PGX.

Essais cliniques associés

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

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Dispositifs connexes (Code : PGX)

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Source officielle

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