INFLUENZA A/B RAPID TEST, CAT NO 2158 663— 510(k) K011684

Name: FDA 510(k) clearance K011684
Creator: U.S. Food and Drug Administration
Published: 2001-11-30

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K011684 for INFLUENZA A/B RAPID TEST, CAT NO 2158 663, Substantially Equivalent on 2001-11-30. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2001-05-30
Decision date: 2001-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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