Submission Details
| 510(k) Number | K193490 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SensiTox C. difficile Toxin Test
Jul 2021
Decision
569d
Days
Class 1
Risk
About This 510(k) Submission
K193490 is an FDA 510(k) clearance for the SensiTox C. difficile Toxin Test, 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 review panel. Regulated under 21 CFR 866.2660.
Device Classification
| Product Code | LLH — Reagents, Clostridium Difficile Toxin |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2660 |
Manufacturer
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