MDx-Chex for BCID2
by Streck, Inc.
510(k) K212576
MDx-Chex for BCID2 is a Class II device made by Streck, Inc., cleared under FDA 510(k) K212576 on 19 Jan 2022, 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 | NumberK212576 | Date19 Jan 2022 | StatusActive |
Official records
- FDA 510(k) database K212576
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- Withdrawn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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