Cleared Traditional

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.

K900974 · Stellar Bio Systems, Inc. · Microbiology
Apr 1990
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K900974 is an FDA 510(k) clearance for the INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI., a Antiserum, Fluorescent, Epstein-barr Virus (Class I — General Controls, product code JRY), submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on April 16, 1990, 45 days after receiving the submission on March 2, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K900974 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1990
Decision Date April 16, 1990
Days to Decision 45 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