Name: Predicase
Price: 199 USD

K-number	K220999
Device name	Hipro Glycosylated Hemoglobin (HbA1c) Test System
Applicant	Shijiazhuang Hipro Biotechnology Co., Ltd.
Product code	PDJ
Device class	Class II
Decision date	Sep 12, 2024
Decision	Substantially Equivalent
Regulation	862.1373

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Source

View the full FDA submission: accessdata.fda.gov

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Hipro Glycosylated Hemoglobin (HbA1c) Test System

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