DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET— 510(k) K940569

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K940569 for DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET, Substantially Equivalent on 1994-07-13. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 1994-02-08
Decision date: 1994-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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