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FDA 510(k)

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

K-Number: K171792 · 2017-09-29

ApplicantAlere Scarborough, Inc.
Decision Date2017-09-29
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit is a medical device manufactured by Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2017-09-29 under approval number K171792. 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 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit?

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K171792.

When was Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit approved by the FDA?

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit received FDA 510(k) clearance on 2017-09-29, under approval number K171792.

What company makes Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit?

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit is manufactured by Alere Scarborough, Inc..

What is the FDA product code for Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit?

The FDA product code for Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit is OCC.

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Other Devices by Alere Scarborough, Inc.

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Related Devices (Code: OCC)

K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc. K152579FilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLC K161814Solana Influenza A+B AssayQuidel Corporation K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. K161220ARIES® Flu A/B & RSV AssayLuminex Corporation K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.

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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