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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) 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. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K221925.

When did ID NOW COVID-19 2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for ID NOW COVID-19 2.0?

The FDA 510(k) record lists Abbott Diagnostics Scarborough, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Abbott Diagnostics 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.

K250273BinaxNOW COVID-19 Ag CardK243518BinaxNOW™ COVID-19 Antigen Self TestK232775ID NOW Influenza A & B 2PMA P940035System, test, tumor marker, for detection of bladder cancerK220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2K191534ID NOW Influenza A & B 2

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Related Devices (Code: QWR)

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.

K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc.K223783cobas SARS-CoV-2 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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