VANCOMYCIN FPIA REAGENT SET— 510(k) K955716

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K955716 for VANCOMYCIN FPIA REAGENT SET, Substantially Equivalent on 1996-02-16. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code LEH
Advisory panel: Clinical Toxicology
Date received: 1995-12-15
Decision date: 1996-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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