MDx-Chex for BCY— 510(k) K254167

Name: FDA 510(k) clearance K254167
Creator: U.S. Food and Drug Administration
Published: 2026-03-17

Substantially Equivalent

Streck, LLC

FDA 510(k) clearance K254167 for MDx-Chex for BCY, Substantially Equivalent on 2026-03-17. Applicant: Streck, LLC. Device class: 2.

Summary

Streck's MDx-Chex for BCY is filed under PMN, assayed external control material for microbiology nucleic acid amplification (NAT) assays. The record doesn't describe the product beyond its name and that code name.

Class II, 21 CFR 866.3920. It was a Traditional 510(k), and Microbiology is both the classification panel and the review panel.

Streck filed from La Vista, Nebraska. The decision came 84 calendar days after FDA received it (December 23, 2025 to March 17, 2026).

Clearance details

Applicant: Streck, LLC
Product code: Product code PMN
Device class: Class 2
Regulation: 21 CFR 866.3920
Advisory panel: Microbiology
Date received: 2025-12-23
Decision date: 2026-03-17
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.