Documento fuente o registro público

FDA 510(k) K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

FDA 510(k) index record K200904. Device: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8. Applicant as listed: Tosoh Bioscience, Inc.. Decision date: 2021-08-05.

OtherU.S. Food and Drug Administration (FDA)2021-08-05

Fuente

"device_name": "Tosoh Automated Glycohemoglobin Analyzer HLC-723G8"

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

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K200904.

Device name: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8. Applicant as listed: Tosoh Bioscience, Inc..

Decision date: 2021-08-05. Decision wording: Substantially Equivalent.

Product code: PDJ. Regulation: 21 CFR 862.1373. Medical specialty: Clinical Chemistry.

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.

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