Cleared Traditional

IMMUNOCARD MONO

K930778 · Meridian Diagnostics, Inc. · Immunology
Dec 1993
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K930778 is an FDA 510(k) clearance for the IMMUNOCARD MONO, a System, Test, Infectious Mononucleosis (Class II — Special Controls, product code KTN), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 27, 1993, 314 days after receiving the submission on February 16, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5640.

Submission Details

510(k) Number K930778 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1993
Decision Date December 27, 1993
Days to Decision 314 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code KTN — System, Test, Infectious Mononucleosis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5640

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