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 |