AMYLASE REAGENT (PROCEDURE 577)— 510(k) K913858

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K913858 for AMYLASE REAGENT (PROCEDURE 577), Substantially Equivalent on 1991-09-11. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1991-08-27
Decision date: 1991-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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