Name: Predicase
Price: 199 USD

K-number	K992803
Device name	SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
Applicant	Sigma Diagnostics, Inc.
Product code	CHH
Device class	Class I
Decision date	Sep 13, 1999
Decision	Substantially Equivalent
Regulation	862.1175

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Source

View the full FDA submission: accessdata.fda.gov

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SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP

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