K-number	K024002
Device name	PENTRA 80
Applicant	Abx Diagnostics
Product code	GKZ
Device class	Class II
Decision date	Jan 3, 2003
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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PENTRA 80

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