MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT— 510(k) K861379

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K861379 for MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT, Substantially Equivalent on 1986-07-16. Applicant: Serono Diagnostics, Inc..

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code LKT
Advisory panel: Microbiology
Date received: 1986-04-14
Decision date: 1986-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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