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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Streck, LLC. It received FDA 510(k) clearance on 2026-03-17 under 510(k) 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. The listed applicant is Streck, LLC. The 510(k) number is K254167.

When did MDx-Chex for BCY receive FDA 510(k) clearance?

MDx-Chex for BCY received FDA 510(k) clearance on 2026-03-17, under 510(k) number K254167.

Who is the listed applicant for MDx-Chex for BCY?

The FDA 510(k) record lists Streck, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDx-Chex for BCY?

The FDA product code for MDx-Chex for BCY is PMN.

Other records listing Streck, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260041MDx-Chex for BCPK254166MDx-Chex for BCNK231776Cell-Free DNA BCTK231223MDx-Chex for BC-GNK231221MDx-Chex for BC-GPK212576MDx-Chex for BCID2

View all 12 devices →

Related Devices (Code: PMN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLCK260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLCK254166MDx-Chex for BCNStreckK251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc.

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.

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