Name: Predicase
Price: 199 USD

K-number	K081182
Device name	MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN
Applicant	Siemens
Product code	JWY
Device class	Class II
Decision date	Aug 8, 2008
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-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN

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