Name: Predicase
Price: 199 USD

K-number	K153651
Device name	Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
Applicant	Beckman Coulter, Inc.
Product code	JLW
Device class	Class II
Decision date	Aug 18, 2016
Decision	Substantially Equivalent
Regulation	862.1690

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Source

View the full FDA submission: accessdata.fda.gov

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Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

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