Name: Predicase
Price: 199 USD

K-number	K032134
Device name	TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
Applicant	Kronus Market Development Associates, Inc.
Product code	JZO
Device class	Class II
Decision date	Sep 10, 2003
Decision	Substantially Equivalent
Regulation	866.5870

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Source

View the full FDA submission: accessdata.fda.gov

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TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT

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