PHENYTOIN FPIA REAGENT SET— 510(k) K870953

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K870953 for PHENYTOIN FPIA REAGENT SET, Substantially Equivalent on 1987-03-31. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code DIP
Advisory panel: Clinical Toxicology
Date received: 1987-03-10
Decision date: 1987-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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