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FDA 510(k)

ID NOW Influenza A & B 2

K-Number: K232775 · 2023-10-10

ApplicantAbbott Diagnostics Scarborough, Inc.
Decision Date2023-10-10
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ID NOW Influenza A & B 2 is a medical device manufactured by Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2023-10-10 under approval number K232775. 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 ID NOW Influenza A & B 2?

ID NOW Influenza A & B 2 is a medical device that received FDA 510(k) clearance on 2023-10-10. It is manufactured by Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K232775.

When was ID NOW Influenza A & B 2 approved by the FDA?

ID NOW Influenza A & B 2 received FDA 510(k) clearance on 2023-10-10, under approval number K232775.

What company makes ID NOW Influenza A & B 2?

ID NOW Influenza A & B 2 is manufactured by Abbott Diagnostics Scarborough, Inc..

What is the FDA product code for ID NOW Influenza A & B 2?

The FDA product code for ID NOW Influenza A & B 2 is OCC.

Other Devices by Abbott Diagnostics 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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