SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094— 510(k) K992711

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K992711 for SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094, Substantially Equivalent on 1999-12-06. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: 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.