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FDA 510(k)

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

K-Number: K173653 · 2018-05-02

ApplicantAlere Scarborough, Inc.
Decision Date2018-05-02
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit is a medical device manufactured by Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2018-05-02 under approval number K173653. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K173653.

When was Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit approved by the FDA?

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 approval number K173653.

What company makes 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 manufactured by Alere Scarborough, Inc..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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