Name: Predicase
Price: 199 USD

K-number	K893754
Device name	CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	JTN
Device class	Class II
Decision date	Jul 14, 1989
Decision	Substantially Equivalent
Regulation	866.1620

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Source

View the full FDA submission: accessdata.fda.gov

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CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS

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