Name: Predicase
Price: 199 USD

K-number	K043341
Device name	BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant	Bio-Rad Laboratories, Inc.
Product code	NVI
Device class	Class II
Decision date	Oct 27, 2005
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

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