K001569

Substantially Equivalent

INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)

Applicant: Sigma Diagnostics, Inc.
Product code: JFJ
Advisory panel: Clinical Chemistry
Date received: 2000-05-19
Decision date: 2000-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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