Name: Predicase
Price: 199 USD

K-number	K033482
Device name	MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
Applicant	Dade Behring, Inc.
Product code	LON
Device class	Class II
Decision date	Nov 26, 2003
Decision	Substantially Equivalent
Regulation	866.1645

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Source

View the full FDA submission: accessdata.fda.gov

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MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

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