FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SensiTox C. difficile Toxin Test
K Number: K193490
·
Decision Jul 8, 2021
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
2
Review Days
569
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Basic Information
- Device Name
- SensiTox C. difficile Toxin Test
- K Number
- K193490
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- First Light Diagnostics, Inc.
- Date Received
- December 17, 2019
- Decision Date
- July 8, 2021
- Product Code
- LLH
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | FDA class 1 | Microbiology |
Similar 510(k) Clearances
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Other Clearances by First Light Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232545 | The SensiTox B. anthracis Toxin Test | Nov 20, 2023 | Substantially Equivalent |