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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 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.

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. 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.

Other records listing Alere Scarborough, Inc. as applicant

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Related Devices (Code: PGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLCK201269Accula Strep A TestMesa Biotech, Inc.K183366GenePOC Strep AGenepoc, Inc.K173398Xpert Xpress Strep ACepheidK172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex CorporationK172126Xpert Xpress Strep ACepheid

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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