Name: Predicase
Price: 199 USD

K-number	K240315
Device name	INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)
Applicant	Siemens Healthcare Diagnostics Products GmbH
Product code	QLU
Device class	Class II
Decision date	Oct 10, 2024
Decision	Substantially Equivalent
Regulation	864.7295

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Source

View the full FDA submission: accessdata.fda.gov

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INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

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