FDA 510(k)

The SensiTox B. anthracis Toxin Test

K-Number: K232545 · 2023-11-20

Decision Date2023-11-20

Product CodeQUU

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

The SensiTox B. anthracis Toxin Test is the device name listed in this FDA 510(k) record. The listed applicant is First Light Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-20 under 510(k) number K232545. The device is classified under product code QUU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The SensiTox B. anthracis Toxin Test?

The SensiTox B. anthracis Toxin Test is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is First Light Diagnostics, Inc.. The 510(k) number is K232545.

When did The SensiTox B. anthracis Toxin Test receive FDA 510(k) clearance?

The SensiTox B. anthracis Toxin Test received FDA 510(k) clearance on 2023-11-20, under 510(k) number K232545.

Who is the listed applicant for The SensiTox B. anthracis Toxin Test?

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

What is the FDA product code for The SensiTox B. anthracis Toxin Test?

The FDA product code for The SensiTox B. anthracis Toxin Test is QUU.

Other records listing First Light Diagnostics, 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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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.