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

Name: FDA 510(k) clearance K861379
Creator: U.S. Food and Drug Administration
Published: 1986-07-16

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.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code LKT
Device class: Class 1
Regulation: 21 CFR 866.3480
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 ↗

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