The SensiTox B. anthracis Toxin Test
K-Number: K232545 · 2023-11-20
ApplicantFirst Light Diagnostics, Inc.
Decision Date2023-11-20
Product CodeQUU
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
The SensiTox B. anthracis Toxin Test is a medical device manufactured by First Light Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-20 under approval number K232545. The device is classified under product code QUU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The SensiTox B. anthracis Toxin Test?
The SensiTox B. anthracis Toxin Test is a medical device that received FDA 510(k) clearance on 2023-11-20. It is manufactured by First Light Diagnostics, Inc.. The 510(k) number is K232545.
When was The SensiTox B. anthracis Toxin Test approved by the FDA?
The SensiTox B. anthracis Toxin Test received FDA 510(k) clearance on 2023-11-20, under approval number K232545.
What company makes The SensiTox B. anthracis Toxin Test?
The SensiTox B. anthracis Toxin Test is manufactured by First Light Diagnostics, Inc..
What is the FDA product code for The SensiTox B. anthracis Toxin Test?
The FDA product code for The SensiTox B. anthracis Toxin Test is QUU.
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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.