Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

K-Number: K173932 · 2018-01-26

ApplicantAlere Scarborough, Inc.
Decision Date2018-01-26
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 is a medical device manufactured by Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2018-01-26 under approval number K173932. 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 Strep A, Alere i RSV, Alere i Influenza A & B 2?

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2018-01-26. It is manufactured by Alere Scarborough, Inc.. The 510(k) number is K173932.

When was Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 approved by the FDA?

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 received FDA 510(k) clearance on 2018-01-26, under approval number K173932.

What company makes Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2?

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 is manufactured by Alere Scarborough, Inc..

What is the FDA product code for Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2?

The FDA product code for Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 is OCC.

Other Devices by Alere Scarborough, Inc.

K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit K161364BinaxNOW G6PD Test K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

View all 11 devices →

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.

↑