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FDA 510(k)

Accula Flu A/Flu B Test

K-Number: K171641 · 2018-02-06

ApplicantMesa Biotech, Inc.
Decision Date2018-02-06
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Accula Flu A/Flu B 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 2018-02-06 under 510(k) number K171641. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accula Flu A/Flu B Test?

Accula Flu A/Flu B Test is a medical device that received FDA 510(k) clearance on 2018-02-06. The listed applicant is Mesa Biotech, Inc.. The 510(k) number is K171641.

When did Accula Flu A/Flu B Test receive FDA 510(k) clearance?

Accula Flu A/Flu B Test received FDA 510(k) clearance on 2018-02-06, under 510(k) number K171641.

Who is the listed applicant for Accula Flu A/Flu B 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 Flu A/Flu B Test?

The FDA product code for Accula Flu A/Flu B Test is OZE.

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 TestK181443Accula RSV Test

Related Devices (Code: OZE)

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.

K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)Centers for Disease Control and PreventionK243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)Centers for Disease Control and PreventionK241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)Centers for Disease Control and PreventionK230236Lyra Influenza A+B AssayQuidel CorporationK220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and Prevention

Official Source

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