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FDA 510(k)

Accula RSV Test

K-Number: K181443 · 2018-11-23

ApplicantMesa Biotech, Inc.
Decision Date2018-11-23
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Accula RSV Test is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K181443. 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 Accula RSV Test?

Accula RSV Test is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Mesa Biotech, Inc.. The 510(k) number is K181443.

When did Accula RSV Test receive FDA 510(k) clearance?

Accula RSV Test received FDA 510(k) clearance on 2018-11-23, under 510(k) number K181443.

Who is the listed applicant for Accula RSV Test?

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

What is the FDA product code for Accula RSV Test?

The FDA product code for Accula RSV Test is OCC.

Other records listing Mesa Biotech, 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.

K201269Accula Strep A TestK171641Accula Flu A/Flu B Test

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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