HEMAGEN ENA SCL-70 KIT (EIA METHOD)— 510(k) K915282

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K915282 for HEMAGEN ENA SCL-70 KIT (EIA METHOD), Substantially Equivalent on 1992-02-12. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 1991-11-25
Decision date: 1992-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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