IMMUNOCARD ROTAVIRUS— 510(k) K933587

Name: FDA 510(k) clearance K933587
Creator: U.S. Food and Drug Administration
Published: 1994-02-03

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K933587 for IMMUNOCARD ROTAVIRUS, Substantially Equivalent on 1994-02-03. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1993-07-26
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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