Documento fuente o registro público

FDA 510(k) K212576 — MDx-Chex for BCID2

FDA 510(k) index record K212576. Device: MDx-Chex for BCID2. Applicant as listed: Streck, Inc.. Decision date: 2022-01-19.

OtherU.S. Food and Drug Administration (FDA)2022-01-19

Fuente

"device_name": "MDx-Chex for BCID2"
api.fda.gov · Consultado el 2026-10-30

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-31

Disclaimer

professional use

References

FDA 510(k) public index record K212576.

Device name: MDx-Chex for BCID2. Applicant as listed: Streck, Inc..

Decision date: 2022-01-19. Decision wording: Substantially Equivalent.

Product code: PMN. Regulation: 21 CFR 866.3920. Medical specialty: Microbiology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

Interested in these solutions?

Submit a sourcing request with the assays, volumes, and timeline of your own project.

Solicitar cotización

FDA 510(k) K212576 — MDx-Chex for BCID2

Fuente

Review and references

Interested in these solutions?

Explorar más

FDA 510(k) K262432 — CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

FDA 510(k) K262576 — twiist Loop Algorithm

FDA 510(k) K260827 — Oncomine Dx Express Test

Fuente

Review and references

Interested in these solutions?

Explorar más

FDA 510(k) K262432 — CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

FDA 510(k) K262576 — twiist Loop Algorithm

FDA 510(k) K260827 — Oncomine  Dx Express Test

FDA 510(k) K260827 — Oncomine Dx Express Test