Name: Predicase
Price: 199 USD

K-number	K863525
Device name	DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	JSI
Device class	Class I
Decision date	Sep 19, 1986
Decision	Substantially Equivalent
Regulation	866.2360

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Source

View the full FDA submission: accessdata.fda.gov

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DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS

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