Name: Predicase
Price: 199 USD

K-number	K230790
Device name	Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
Applicant	Abbott Laboratories
Product code	DHA
Device class	Class II
Decision date	May 19, 2023
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

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