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FDA 510(k)

FluChip-8G Influenza A+B Assay

K-Number: K182513 · 2019-04-22

ApplicantIndevr, Inc.
Decision Date2019-04-22
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FluChip-8G Influenza A+B Assay is the device name listed in this FDA 510(k) record. The listed applicant is Indevr, Inc.. It received FDA 510(k) clearance on 2019-04-22 under 510(k) number K182513. 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 FluChip-8G Influenza A+B Assay?

FluChip-8G Influenza A+B Assay is a medical device that received FDA 510(k) clearance on 2019-04-22. The listed applicant is Indevr, Inc.. The 510(k) number is K182513.

When did FluChip-8G Influenza A+B Assay receive FDA 510(k) clearance?

FluChip-8G Influenza A+B Assay received FDA 510(k) clearance on 2019-04-22, under 510(k) number K182513.

Who is the listed applicant for FluChip-8G Influenza A+B Assay?

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

What is the FDA product code for FluChip-8G Influenza A+B Assay?

The FDA product code for FluChip-8G Influenza A+B Assay is OZE.

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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