THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS— 510(k) K942192

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K942192 for THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS, Substantially Equivalent on 1994-07-13. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code LER
Advisory panel: Clinical Toxicology
Date received: 1994-05-04
Decision date: 1994-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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