The SensiTox B. anthracis Toxin Test— 510(k) K232545

Name: FDA 510(k) clearance K232545
Creator: U.S. Food and Drug Administration
Published: 2023-11-20

Substantially Equivalent

First Light Diagnostics, Inc.

FDA 510(k) clearance K232545 for The SensiTox B. anthracis Toxin Test, Substantially Equivalent on 2023-11-20. Applicant: First Light Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: First Light Diagnostics, Inc.
Product code: Code QUU
Device class: Class 2
Regulation: 21 CFR 866.3046
Advisory panel: Microbiology
Date received: 2023-08-22
Decision date: 2023-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

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