FDA 510(k)

SensiTox C. difficile Toxin Test

K-Number: K193490 · 2021-07-08

Decision Date2021-07-08

Product CodeLLH

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SensiTox C. difficile 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 2021-07-08 under 510(k) number K193490. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SensiTox C. difficile Toxin Test?

SensiTox C. difficile Toxin Test is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is First Light Diagnostics, Inc.. The 510(k) number is K193490.

When did SensiTox C. difficile Toxin Test receive FDA 510(k) clearance?

SensiTox C. difficile Toxin Test received FDA 510(k) clearance on 2021-07-08, under 510(k) number K193490.

Who is the listed applicant for SensiTox C. difficile 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 SensiTox C. difficile Toxin Test?

The FDA product code for SensiTox C. difficile Toxin Test is LLH.

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.