Cleared Traditional

EBV-VCA IGG ELISA TEST SYSTEM

K981812 · Diamedix Corp. · Microbiology
Mar 1999
Decision
286d
Days
Class 1
Risk

About This 510(k) Submission

K981812 is an FDA 510(k) clearance for the EBV-VCA IGG ELISA TEST SYSTEM, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Diamedix Corp. (Columbia, US). The FDA issued a Cleared decision on March 4, 1999, 286 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 K981812 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1998
Decision Date March 04, 1999
Days to Decision 286 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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