FDA 510(k)

Accula RSV Test

K-Number: K181443 · 2018-11-23

Decision Date2018-11-23

Product CodeOCC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Accula RSV Test is a medical device manufactured by Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2018-11-23 under approval 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. It is manufactured by Mesa Biotech, Inc.. The 510(k) number is K181443.

When was Accula RSV Test approved by the FDA?

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

What company makes Accula RSV Test?

Accula RSV Test is manufactured by Mesa Biotech, Inc..

What is the FDA product code for Accula RSV Test?

The FDA product code for Accula RSV Test is OCC.

Other Devices by Mesa Biotech, Inc.

K171641Accula Flu A/Flu B Test K201269Accula Strep A Test

Related Devices (Code: OCC)

K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc. K152579FilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLC K161814Solana Influenza A+B AssayQuidel Corporation K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. K161220ARIES® Flu A/B & RSV AssayLuminex Corporation K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.