Name: Predicase
Price: 199 USD

K-number	K032706
Device name	MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
Applicant	Dade Behring, Inc.
Product code	JWY
Device class	Class II
Decision date	Feb 10, 2004
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML

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