Name: Predicase
Price: 199 USD

K-number	K881115
Device name	BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	JSG
Device class	Class I
Decision date	Mar 24, 1988
Decision	Substantially Equivalent
Regulation	866.2300

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Source

View the full FDA submission: accessdata.fda.gov

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BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA

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