Name: Predicase
Price: 199 USD

K-number	K220977
Device name	ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
Applicant	Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Product code	JGS
Device class	Class II
Decision date	Jul 20, 2023
Decision	Substantially Equivalent
Regulation	862.1665

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Source

View the full FDA submission: accessdata.fda.gov

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ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

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