SensiTox C. difficile Toxin Test
K-Number: K193490 · 2021-07-08
ApplicantFirst Light Diagnostics, Inc.
Decision Date2021-07-08
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
SensiTox C. difficile Toxin Test is a medical device manufactured by First Light Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-07-08 under approval 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. It is manufactured by First Light Diagnostics, Inc.. The 510(k) number is K193490.
When was SensiTox C. difficile Toxin Test approved by the FDA?
SensiTox C. difficile Toxin Test received FDA 510(k) clearance on 2021-07-08, under approval number K193490.
What company makes SensiTox C. difficile Toxin Test?
SensiTox C. difficile Toxin Test is manufactured by First Light Diagnostics, Inc..
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 Devices by First Light Diagnostics, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.