K-number	K935454
Device name	DPX TISSUE QUANTIFICATION OUTPUT
Applicant	Lunar Corp.
Product code	JAK
Device class	Class II
Decision date	Oct 19, 1995
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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DPX TISSUE QUANTIFICATION OUTPUT

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