Cleared Traditional

EBNA IGG ELISA TEST

K935730 · Gull Laboratories, Inc. · Microbiology
Sep 1995
Decision
657d
Days
Class 1
Risk

About This 510(k) Submission

K935730 is an FDA 510(k) clearance for the EBNA IGG ELISA TEST, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 1995, 657 days after receiving the submission on December 1, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K935730 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1993
Decision Date September 19, 1995
Days to Decision 657 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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