MDx-Chex for BCP
K-Number: K260041 · 2026-03-27
ApplicantStreck, LLC
Decision Date2026-03-27
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
MDx-Chex for BCP is a medical device manufactured by Streck, LLC. It received FDA 510(k) clearance on 2026-03-27 under approval number K260041. 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 BCP?
MDx-Chex for BCP is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Streck, LLC. The 510(k) number is K260041.
When was MDx-Chex for BCP approved by the FDA?
MDx-Chex for BCP received FDA 510(k) clearance on 2026-03-27, under approval number K260041.
What company makes MDx-Chex for BCP?
MDx-Chex for BCP is manufactured by Streck, LLC.
What is the FDA product code for MDx-Chex for BCP?
The FDA product code for MDx-Chex for BCP 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.