VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES— 510(k) K984596

Name: FDA 510(k) clearance K984596
Creator: U.S. Food and Drug Administration
Published: 1999-03-04

Substantially Equivalent

Zymetx, Inc.

FDA 510(k) clearance K984596 for VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES, Substantially Equivalent on 1999-03-04. Applicant: Zymetx, Inc.. Device class: 1.

Clearance details

Applicant: Zymetx, Inc.
Product code: Code GNR
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1998-12-28
Decision date: 1999-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

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