ANTI-ENA ANTIBODY TEST (SM)— 510(k) K920385

Substantially Equivalent

Immco Diagnostics, Inc.

FDA 510(k) clearance K920385 for ANTI-ENA ANTIBODY TEST (SM), Substantially Equivalent on 1992-03-30. Applicant: Immco Diagnostics, Inc..

Clearance details

Applicant: Immco Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 1992-01-30
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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