510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232545Substantially Equivalent

The SensiTox B. anthracis Toxin Test

First Light Diagnostics, Inc., Chelmsford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232545 is the FDA 510(k) clearance record for The SensiTox B. anthracis Toxin Test, a class II device, cleared for First Light Diagnostics, Inc. on under FDA product code QUU (Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples). FDA's definition for product code QUU reads: "A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human...". FDA records list 2 510(k) clearances for First Light Diagnostics, Inc., from to . As of , FDA records show no recalls naming K232545.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QUU Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
Regulation
21 CFR 866.3046
Device class
Class II
Review panel
Microbiology
Applicant
First Light Diagnostics, Inc. 2 Omni Way, Chelmsford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QUU

Trailing 12 months

FDA records hold no clearances under product code QUU in the trailing twelve months.

FDA records show no clearances under product code QUU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QUU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260