ENZYGNOST ANTI-CMV IGM TEST— 510(k) K861363

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K861363 for ENZYGNOST ANTI-CMV IGM TEST, Substantially Equivalent on 1986-07-21. Applicant: Behring Diagnostics, Inc..

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LKQ
Advisory panel: Microbiology
Date received: 1986-04-10
Decision date: 1986-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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