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

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..

Clearance details

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

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