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FDA 510(k)

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

K-Number: K161375 · 2016-08-18

ApplicantAlere Scarborough, Inc.
Decision Date2016-08-18
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is a medical device manufactured by Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2016-08-18 under approval number K161375. 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 RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K161375.

When was Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit approved by the FDA?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit received FDA 510(k) clearance on 2016-08-18, under approval number K161375.

What company makes Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is manufactured by Alere Scarborough, Inc..

What is the FDA product code for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

The FDA product code for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is OCC.

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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 K161220ARIES® Flu A/B & RSV AssayLuminex Corporation K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc. K160068FilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLC

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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