Name: Predicase
Price: 199 USD

K-number	K052308
Device name	ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
Applicant	Fisher Diagnostics
Product code	JZO
Device class	Class II
Decision date	May 10, 2006
Decision	Substantially Equivalent
Regulation	866.5870

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM

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