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FDA 510(k)

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

K-Number: K163266 · 2016-12-21

ApplicantAlere Scarborough, Inc.
Decision Date2016-12-21
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K163266.

When was Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument approved by the FDA?

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 approval number K163266.

What company makes 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 manufactured by Alere Scarborough, Inc..

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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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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