Cleared Traditional

EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM

K901156 · Granbio, Inc. · Microbiology
Sep 1990
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K901156 is an FDA 510(k) clearance for the EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM, 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 September 12, 1990, 183 days after receiving the submission on March 13, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K901156 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 1990
Decision Date September 12, 1990
Days to Decision 183 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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