Name: Predicase
Price: 199 USD

K-number	K250073
Device name	Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
Applicant	Tosoh Bioscience, Inc.
Product code	PDJ
Device class	Class II
Decision date	Oct 3, 2025
Decision	Substantially Equivalent
Regulation	862.1373

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

Everything you need for a 510(k) submission. Nothing you don't.