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

Name: FDA 510(k) clearance K200904
Creator: U.S. Food and Drug Administration
Published: 2021-08-05

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K200904 for Tosoh Automated Glycohemoglobin Analyzer HLC-723G8, Substantially Equivalent on 2021-08-05. Applicant: Tosoh Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2020-04-06
Decision date: 2021-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

Download summary PDF View on FDA.gov ↗

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