MDx-Chex for BCY
K-Number: K254167 · 2026-03-17
ApplicantStreck, LLC
Decision Date2026-03-17
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
MDx-Chex for BCY is a medical device manufactured by Streck, LLC. It received FDA 510(k) clearance on 2026-03-17 under approval number K254167. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MDx-Chex for BCY?
MDx-Chex for BCY is a medical device that received FDA 510(k) clearance on 2026-03-17. It is manufactured by Streck, LLC. The 510(k) number is K254167.
When was MDx-Chex for BCY approved by the FDA?
MDx-Chex for BCY received FDA 510(k) clearance on 2026-03-17, under approval number K254167.
What company makes MDx-Chex for BCY?
MDx-Chex for BCY is manufactured by Streck, LLC.
What is the FDA product code for MDx-Chex for BCY?
The FDA product code for MDx-Chex for BCY is PMN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.