K193490 is an FDA 510(k) clearance for the SensiTox C. difficile Toxin Test. This device is classified as a Reagents, Clostridium Difficile Toxin (Class I - General Controls, product code LLH).
Submitted by First Light Diagnostics, Inc. (Chelmsford, US). The FDA issued a Cleared decision on July 8, 2021, 569 days after receiving the submission on December 17, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K193490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2019 |
| Decision Date | July 08, 2021 |
| Days to Decision | 569 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LLH - Reagents, Clostridium Difficile Toxin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |