Cleared Traditional

EBV-EA(D) IGG ELISA TEST

K940093 · Gull Laboratories, Inc. · Microbiology
Sep 1995
Decision
616d
Days
Class 1
Risk

About This 510(k) Submission

K940093 is an FDA 510(k) clearance for the EBV-EA(D) IGG ELISA TEST, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 15, 1995, 616 days after receiving the submission on January 7, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K940093 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1994
Decision Date September 15, 1995
Days to Decision 616 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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