Medical Device Manufacturer · US , Chelmsford , MA

First Light Diagnostics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2021
2
Total
2
Cleared
0
Denied

First Light Diagnostics, Inc. has 2 FDA 510(k) cleared medical devices. Based in Chelmsford, US.

Last cleared in 2023. Active since 2021. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by First Light Diagnostics, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by MDC Associates, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - First Light Diagnostics, Inc.
2 devices
1-2 of 2
Cleared Nov 20, 2023
The SensiTox B. anthracis Toxin Test
K232545 · QUU
Microbiology · 90d
Cleared Jul 08, 2021
SensiTox C. difficile Toxin Test
K193490 · LLH
Microbiology · 569d
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