Name: Predicase
Price: 199 USD

K-number	DEN230024
Device name	Technozym ADAMTS13 Activity
Applicant	Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM
Product code	SAC
Device class	Class II
Decision date	Feb 28, 2024
Decision	Not Substantially Equivalent
Regulation	864.7297

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Source

View the full FDA submission: accessdata.fda.gov

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Technozym ADAMTS13 Activity

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