ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST— 510(k) K993048

Name: FDA 510(k) clearance K993048
Creator: U.S. Food and Drug Administration
Published: 1999-12-20

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K993048 for ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST, Substantially Equivalent on 1999-12-20. 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: 1999-09-10
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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