Name: Predicase
Price: 199 USD

K-number	K013095
Device name	WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
Applicant	Wiener Laboratories Saic
Product code	CEO
Device class	Class I
Decision date	Nov 16, 2001
Decision	Substantially Equivalent
Regulation	862.1580

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Source

View the full FDA submission: accessdata.fda.gov

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WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311

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