Cleared Traditional

IMMUNOCARD MYCOPLASMA

K934550 · Meridian Diagnostics, Inc. · Microbiology
Sep 1994
Decision
363d
Days
Class 1
Risk

About This 510(k) Submission

K934550 is an FDA 510(k) clearance for the IMMUNOCARD MYCOPLASMA, a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I — General Controls, product code LJZ), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 20, 1994, 363 days after receiving the submission on September 22, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number K934550 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1993
Decision Date September 20, 1994
Days to Decision 363 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3375

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