The following data is part of a premarket notification filed by First Light Diagnostics, Inc. with the FDA for Sensitox C. Difficile Toxin Test.
Device ID | K193490 |
510k Number | K193490 |
Device Name: | SensiTox C. Difficile Toxin Test |
Classification | Reagents, Clostridium Difficile Toxin |
Applicant | First Light Diagnostics, Inc. 2 Omni Way Chelmsford, MA 01824 |
Contact | Joanne Spadoro |
Correspondent | Fran White MDC Associates, LLC 180 Cabot Street Beverly, MA 01915 |
Product Code | LLH |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-17 |
Decision Date | 2021-07-08 |