Cleared Traditional

IS EBV-EBNA-1 IGG ELISA TEST SYSTEM

K981829 · Diamedix Corp. · Microbiology
Feb 1999
Decision
270d
Days
Class 1
Risk

About This 510(k) Submission

K981829 is an FDA 510(k) clearance for the IS EBV-EBNA-1 IGG ELISA TEST SYSTEM, a Antiserum, Cf, Epstein-barr Virus (Class I — General Controls, product code GNP), submitted by Diamedix Corp. (Columbia, US). The FDA issued a Cleared decision on February 16, 1999, 270 days after receiving the submission on May 22, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K981829 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1998
Decision Date February 16, 1999
Days to Decision 270 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GNP — Antiserum, Cf, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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