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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 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 2019-07-11 under 510(k) 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. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K191534.

When did ID NOW Influenza A & B 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for ID NOW Influenza A & B 2?

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 Influenza A & B 2?

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

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.

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Related Devices (Code: OCC)

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.

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV 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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