K992803

Substantially Equivalent

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
Advisory panel: Clinical Chemistry
Date received: 1999-08-19
Decision date: 1999-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.