INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)— 510(k) K001569

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K001569 for INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568), Substantially Equivalent on 2000-06-26. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: 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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