VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES— 510(k) K950838

Name: FDA 510(k) clearance K950838
Creator: U.S. Food and Drug Administration
Published: 1996-06-17

Substantially Equivalent

Zymetx, Inc.

FDA 510(k) clearance K950838 for VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES, Substantially Equivalent on 1996-06-17. Applicant: Zymetx, Inc.. Device class: 1.

Clearance details

Applicant: Zymetx, Inc.
Product code: Code GNT
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1995-02-24
Decision date: 1996-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

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