MDx-Chex for BCN
by Streck
510(k) K254166
MDx-Chex for BCN is a medical device (FDA Class II; FDA product code PMN) made by Streck, cleared under FDA 510(k) K254166 on 23 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 | NumberK254166 | Date23 Mar 2026 | StatusActive |
Official records
- FDA 510(k) database K254166
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- Withdrawn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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