MDx-Chex for BCY— 510(k) K254167

Substantially Equivalent

Streck, LLC

FDA 510(k) clearance K254167 for MDx-Chex for BCY, Substantially Equivalent on 2026-03-17. Applicant: Streck, LLC.

Clearance details

Applicant: Streck, LLC
Product code: Code PMN
Advisory panel: Microbiology
Date received: 2025-12-23
Decision date: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.