Name: Predicase
Price: 199 USD

K-number	K170509
Device name	BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
Applicant	Bio-Rad Laboratories
Product code	PUQ
Device class	Class II
Decision date	May 19, 2017
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

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