Cleared Traditional

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA

K864347 · Granbio, Inc. · Microbiology
Feb 1987
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K864347 is an FDA 510(k) clearance for the INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA, a Antiserum, Cf, Epstein-barr Virus (Class I — General Controls, product code GNP), submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on February 2, 1987, 90 days after receiving the submission on November 4, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K864347 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1986
Decision Date February 02, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

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