K-number	K020687
Device name	DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300
Applicant	Axis-Shield Diagnostics, Ltd.
Product code	JZO
Device class	Class II
Decision date	May 2, 2002
Decision	Substantially Equivalent
Regulation	866.5870

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DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

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