ORTHO HSV ANTIGEN ELISA TEST— 510(k) K854488

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K854488 for ORTHO HSV ANTIGEN ELISA TEST, Substantially Equivalent on 1986-02-04. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code GQN
Advisory panel: Microbiology
Date received: 1985-11-08
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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