Name: Predicase
Price: 199 USD

K-number	K080008
Device name	BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
Applicant	Bio-Rad Laboratories, Inc.
Product code	OMI
Device class	Class II
Decision date	Feb 23, 2009
Decision	Substantially Equivalent
Regulation	866.3510

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Source

View the full FDA submission: accessdata.fda.gov

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BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

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