VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES— 510(k) K971494

Name: FDA 510(k) clearance K971494
Creator: U.S. Food and Drug Administration
Published: 1997-09-10

Substantially Equivalent

Zymetx, Inc.

FDA 510(k) clearance K971494 for VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES, Substantially Equivalent on 1997-09-10. Applicant: Zymetx, Inc.. Device class: 1.

Clearance details

Applicant: Zymetx, Inc.
Product code: Code GNX
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1997-04-24
Decision date: 1997-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

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