510(k) K972794— DIGOXIN DG-II FPIA REAGENT SET

Substantially Equivalent

Sigma Diagnostics, Inc.

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1997-06-06
Decision date: 1997-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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