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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 the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) 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. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K161375.

When did Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Alere i RSV, Alere i Instrument, Alere i RSV 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 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.

Other records listing Alere Scarborough, Inc. as applicant

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.

K190204ID NOW Influenza A & B 2K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderK173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitK173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitK171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

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Related Devices (Code: OCC)

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.

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, 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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