Name: Predicase
Price: 199 USD

K-number	K002453
Device name	ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
Applicant	Beckman Coulter, Inc.
Product code	LGD
Device class	Class II
Decision date	Aug 31, 2000
Decision	Substantially Equivalent
Regulation	866.3780

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Source

View the full FDA submission: accessdata.fda.gov

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ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479

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