Cleared Traditional

EBV-M KIT

K822985 · Litton Bionetics · Microbiology
Dec 1982
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K822985 is an FDA 510(k) clearance for the EBV-M KIT, a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Litton Bionetics (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982, 52 days after receiving the submission on October 12, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K822985 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1982
Decision Date December 03, 1982
Days to Decision 52 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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