MDx-Chex for BCN
K-Number: K254166 · 2026-03-23
ApplicantStreck
Decision Date2026-03-23
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
MDx-Chex for BCN is a medical device manufactured by Streck. It received FDA 510(k) clearance on 2026-03-23 under approval number K254166. 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 BCN?
MDx-Chex for BCN is a medical device that received FDA 510(k) clearance on 2026-03-23. It is manufactured by Streck. The 510(k) number is K254166.
When was MDx-Chex for BCN approved by the FDA?
MDx-Chex for BCN received FDA 510(k) clearance on 2026-03-23, under approval number K254166.
What company makes MDx-Chex for BCN?
MDx-Chex for BCN is manufactured by Streck.
What is the FDA product code for MDx-Chex for BCN?
The FDA product code for MDx-Chex for BCN 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.