Cleared Traditional

IMMUNOCARD STAT! ROTAVIRUS

K971585 · Meridian Diagnostics, Inc. · Microbiology
Aug 1997
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K971585 is an FDA 510(k) clearance for the IMMUNOCARD STAT! 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 August 20, 1997, 111 days after receiving the submission on May 1, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K971585 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1997
Decision Date August 20, 1997
Days to Decision 111 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