Name: Predicase
Price: 199 USD

K-number	K023795
Device name	PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
Applicant	Lin-Zhi International, Inc.
Product code	JXN
Device class	Class II
Decision date	Jan 21, 2003
Decision	Substantially Equivalent
Regulation	862.3700

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Source

View the full FDA submission: accessdata.fda.gov

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PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)

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