SensiTox C. difficile Toxin Test— 510(k) K193490

Name: FDA 510(k) clearance K193490
Creator: U.S. Food and Drug Administration
Published: 2021-07-08

Substantially Equivalent

First Light Diagnostics, Inc.

FDA 510(k) clearance K193490 for SensiTox C. difficile Toxin Test, Substantially Equivalent on 2021-07-08. Applicant: First Light Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: First Light Diagnostics, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2019-12-17
Decision date: 2021-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

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