IGM RF EIA— 510(k) K942908

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K942908 for IGM RF EIA, Substantially Equivalent on 1995-01-20. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code DHR
Advisory panel: Immunology
Date received: 1994-06-21
Decision date: 1995-01-20
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.