Cleared Traditional

EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM

K992587 · Stellar Bio Systems, Inc. · Microbiology
Dec 1999
Decision
142d
Days
Class 1
Risk

About This 510(k) Submission

K992587 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on December 22, 1999, 142 days after receiving the submission on August 2, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K992587 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1999
Decision Date December 22, 1999
Days to Decision 142 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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