K254166
- 510(k) number
- K254166
- Device name
- MDx-Chex for BCN
- Applicant
- Streck NE · US
- Product code
- PMN — Assayed External Control Material For Microbiology N
- Decision date
- 2026-03-23
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K254166.pdf
Official FDA record: K254166
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.