Name: Predicase
Price: 199 USD

K-number	K003259
Device name	ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
Applicant	Beckman Coulter, Inc.
Product code	LGD
Device class	Class II
Decision date	Jun 13, 2001
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, MODEL 34470,34475,34479

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