Cleared Traditional

IMMUNOCARD ROTAVIRUS

K933587 · Meridian Diagnostics, Inc. · Microbiology
Feb 1994
Decision
192d
Days
Class 1
Risk

About This 510(k) Submission

K933587 is an FDA 510(k) clearance for the IMMUNOCARD ROTAVIRUS, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 3, 1994, 192 days after receiving the submission on July 26, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K933587 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1993
Decision Date February 03, 1994
Days to Decision 192 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405