Cleared Traditional

EBNA-1 IGM ELISA TEST SYSTEM

K980598 · Clark Laboratories, Inc. · Microbiology
May 1998
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K980598 is an FDA 510(k) clearance for the EBNA-1 IGM ELISA TEST SYSTEM, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Clark Laboratories, Inc. (Frederick, US). The FDA issued a Cleared decision on May 1, 1998, 73 days after receiving the submission on February 17, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K980598 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 1998
Decision Date May 01, 1998
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLM — Test, Antigen, Nuclear, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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