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FDA 510(k)

MDx-Chex for BC-GP

K-Number: K231221 · 2023-07-27

ApplicantStreck
Decision Date2023-07-27
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MDx-Chex for BC-GP is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K231221. 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-GP?

MDx-Chex for BC-GP is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Streck. The 510(k) number is K231221.

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

MDx-Chex for BC-GP received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231221.

Who is the listed applicant for MDx-Chex for BC-GP?

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

What is the FDA product code for MDx-Chex for BC-GP?

The FDA product code for MDx-Chex for BC-GP is PMN.

Other records listing Streck 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 BCNK254167MDx-Chex for BCYK231776Cell-Free DNA BCTK231223MDx-Chex for BC-GNK212576MDx-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 BCNStreckK254167MDx-Chex for BCYStreck, LLCK251526FilmArray GI Control Panel M238Maine 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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