MDx-Chex for BCP— 510(k) K260041

Substantially Equivalent

Streck, LLC

FDA 510(k) clearance K260041 for MDx-Chex for BCP, Substantially Equivalent on 2026-03-27. Applicant: Streck, LLC. Device class: 2.

Clearance details

Applicant: Streck, LLC
Product code: Code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2026-01-06
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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