K260041
- 510(k) number
- K260041
- Device name
- MDx-Chex for BCP
- Applicant
- Streck, LLC NE · US
- Product code
- PMN — Assayed External Control Material For Microbiology N
- Decision date
- 2026-03-27
- Date received
- 2026-01-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K260041.pdf
Official FDA record: K260041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.