K-number	K820039
Device name	LEECO PRL-QUANT DIAGNOSTIC TEST KIT
Applicant	Leeco Diagnostics, Inc.
Product code	CFT
Device class	Class I
Decision date	Jan 22, 1982
Decision	Substantially Equivalent
Regulation	862.1625

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View the full FDA submission: accessdata.fda.gov

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LEECO PRL-QUANT DIAGNOSTIC TEST KIT

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