Name: Predicase
Price: 199 USD

K-number	K241800
Device name	Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	MRR
Device class	Class I
Decision date	Jul 26, 2024
Decision	Substantially Equivalent
Regulation	862.1475

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Source

View the full FDA submission: accessdata.fda.gov

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Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)

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