Cleared Traditional

EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)

K895707 · Immuno Concepts, Inc. · Microbiology
Dec 1989
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K895707 is an FDA 510(k) clearance for the EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY), a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 8, 1989, 74 days after receiving the submission on September 25, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K895707 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1989
Decision Date December 08, 1989
Days to Decision 74 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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