MDx-Chex for BC-GN
K-Number: K231223 · 2023-07-27
ApplicantStreck
Decision Date2023-07-27
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
MDx-Chex for BC-GN is a medical device manufactured by Streck. It received FDA 510(k) clearance on 2023-07-27 under approval number K231223. 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 BC-GN?
MDx-Chex for BC-GN is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Streck. The 510(k) number is K231223.
When was MDx-Chex for BC-GN approved by the FDA?
MDx-Chex for BC-GN received FDA 510(k) clearance on 2023-07-27, under approval number K231223.
What company makes MDx-Chex for BC-GN?
MDx-Chex for BC-GN is manufactured by Streck.
What is the FDA product code for MDx-Chex for BC-GN?
The FDA product code for MDx-Chex for BC-GN 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.