VIRGO AMA ELISA KIT— 510(k) K971909

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K971909 for VIRGO AMA ELISA KIT, Substantially Equivalent on 1997-06-20. Applicant: Hemagen Diagnostics, Inc..

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code DBM
Advisory panel: Immunology
Date received: 1997-05-23
Decision date: 1997-06-20
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.