INFLUENZA A & B S-ANTIGEN & CONTROLS— 510(k) K802931

Name: FDA 510(k) clearance K802931
Creator: U.S. Food and Drug Administration
Published: 1981-01-12

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K802931 for INFLUENZA A & B S-ANTIGEN & CONTROLS, Substantially Equivalent on 1981-01-12. Applicant: Orion Diagnostica, Inc.. Device class: 1.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code GNX
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1980-11-19
Decision date: 1981-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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