OPUS PSA TEST SYSTEM— 510(k) K964595

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K964595 for OPUS PSA TEST SYSTEM, Substantially Equivalent on 1997-06-24. Applicant: Behring Diagnostics, Inc..

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 1996-11-18
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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