Name: Predicase
Price: 199 USD

K-number	K213987
Device name	ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
Applicant	Biokit, S.A.
Product code	MXJ
Device class	Class II
Decision date	Sep 20, 2023
Decision	Substantially Equivalent
Regulation	866.3305

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

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