Name: Predicase
Price: 199 USD

K-number	K990141
Device name	LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
Applicant	Light Diagnostics
Product code	GQW
Device class	Class II
Decision date	Oct 19, 1999
Decision	Substantially Equivalent
Regulation	866.3900

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Source

View the full FDA submission: accessdata.fda.gov

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LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295

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