Name: Predicase
Price: 199 USD

K-number	K070265
Device name	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
Applicant	Diagnostic Hybrids, Inc.
Product code	GQN
Device class	Class II
Decision date	Oct 24, 2007
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000

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