PRIMIDONE FPIA REAGENT SET AND CALIBRATORS— 510(k) K950028

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K950028 for PRIMIDONE FPIA REAGENT SET AND CALIBRATORS, Substantially Equivalent on 1995-03-21. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code LFT
Advisory panel: Clinical Toxicology
Date received: 1995-01-04
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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