MDx-Chex for BCP
by Streck, LLC
510(k) K260041
MDx-Chex for BCP is a Class II device made by Streck, LLC, cleared under FDA 510(k) K260041 on 27 Mar 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260041 | Date27 Mar 2026 | StatusActive |
Official records
- FDA 510(k) database K260041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PMN
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3920
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
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