Name: Predicase
Price: 199 USD

K-number	K193508
Device name	Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
Applicant	Oxoid Limited (Part of Thermo Fisher Scientific)
Product code	JTN
Device class	Class II
Decision date	Dec 4, 2020
Decision	Substantially Equivalent
Regulation	866.1620

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Source

View the full FDA submission: accessdata.fda.gov

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Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20

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