K992712

Substantially Equivalent

SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334

Applicant: Sigma Diagnostics, Inc.
Product code: GFO
Advisory panel: Hematology
Date received: 1999-08-11
Decision date: 1999-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.