K950028

Substantially Equivalent

PRIMIDONE FPIA REAGENT SET AND CALIBRATORS

Applicant: Sigma Diagnostics, Inc.
Product 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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