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)

ID NOW Influenza A & B 2

K-Number: K191534 · 2019-07-11

ApplicantAbbott Diagnostics Scarborough, Inc.
Decision Date2019-07-11
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 2019-07-11 under approval number K191534. 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 2019-07-11. It is manufactured by Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K191534.

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

ID NOW Influenza A & B 2 received FDA 510(k) clearance on 2019-07-11, under approval number K191534.

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.

K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 K232775ID NOW Influenza A & B 2 K221925ID NOW COVID-19 2.0 K250273BinaxNOW COVID-19 Ag Card K243518BinaxNOW™ COVID-19 Antigen Self Test PMA P940035System, test, tumor marker, for detection of bladder cancer

View all 7 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.

↑