SensiTox C. Difficile Toxin Test

Reagents, Clostridium Difficile Toxin

First Light Diagnostics, Inc.

The following data is part of a premarket notification filed by First Light Diagnostics, Inc. with the FDA for Sensitox C. Difficile Toxin Test.

Pre-market Notification Details

Device IDK193490
510k NumberK193490
Device Name:SensiTox C. Difficile Toxin Test
ClassificationReagents, Clostridium Difficile Toxin
Applicant First Light Diagnostics, Inc. 2 Omni Way Chelmsford,  MA  01824
ContactJoanne Spadoro
CorrespondentFran White
MDC Associates, LLC 180 Cabot Street Beverly,  MA  01915
Product CodeLLH  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2021-07-08

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