Cleared Traditional

COPALIS EBV-M ANTIBODY ASSAY

K991459 · DiaSorin, Inc. · Microbiology
May 1999
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K991459 is an FDA 510(k) clearance for the COPALIS EBV-M ANTIBODY ASSAY, a Antibody Igm, If, Epstein-barr Virus (Class I — General Controls, product code LJN), submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on May 14, 1999, 18 days after receiving the submission on April 26, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K991459 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1999
Decision Date May 14, 1999
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJN — Antibody Igm, If, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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