MDx-Chex for BCY
by Streck, LLC
510(k) K254167
MDx-Chex for BCY is a Class II device made by Streck, LLC, cleared under FDA 510(k) K254167 on 17 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 | NumberK254167 | Date17 Mar 2026 | StatusActive |
Official records
- FDA 510(k) database K254167
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- Withdrawn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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