FDA 510(k)

ID NOW COVID-19 2.0

K-Number: K221925 · 2023-08-10

ApplicantAbbott Diagnostics Scarborough, Inc.

Decision Date2023-08-10

Product CodeQWR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ID NOW COVID-19 2.0 is a medical device manufactured by Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2023-08-10 under approval number K221925. The device is classified under product code QWR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ID NOW COVID-19 2.0?

ID NOW COVID-19 2.0 is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K221925.

When was ID NOW COVID-19 2.0 approved by the FDA?

ID NOW COVID-19 2.0 received FDA 510(k) clearance on 2023-08-10, under approval number K221925.

What company makes ID NOW COVID-19 2.0?

ID NOW COVID-19 2.0 is manufactured by Abbott Diagnostics Scarborough, Inc..

What is the FDA product code for ID NOW COVID-19 2.0?

The FDA product code for ID NOW COVID-19 2.0 is QWR.

Other Devices by Abbott Diagnostics Scarborough, Inc.

K191534ID NOW Influenza A & B 2 K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 K232775ID NOW Influenza A & B 2 K250273BinaxNOW COVID-19 Ag Card K243518BinaxNOW COVID-19 Antigen Self Test PMA P940035System, test, tumor marker, for detection of bladder cancer

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Related Devices (Code: QWR)

K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche 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.