Name: Predicase
Price: 199 USD

K-number	K212778
Device name	Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)
Applicant	Abbott Molecular, Inc.
Product code	QLX
Device class	Class II
Decision date	Jul 15, 2022
Decision	Substantially Equivalent
Regulation	866.3183

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Source

View the full FDA submission: accessdata.fda.gov

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Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

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