Cleared Traditional

EBV IGM TEST

K822734 · Gull Laboratories, Inc. · Microbiology
Dec 1982
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K822734 is an FDA 510(k) clearance for the EBV IGM TEST, a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Gull Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on December 9, 1982, 91 days after receiving the submission on September 9, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K822734 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1982
Decision Date December 09, 1982
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JRY — Antiserum, Fluorescent, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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