Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
by Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC 510(k)
Active
510(k) K163085
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163085 | Date14 Feb 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- OZN
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3130
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent