Cleared Traditional

VIRAL ANTISERA, FLUORESCEIN LABELED

K770216 · Flow Laboratories, Inc. · Immunology
Mar 1977
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K770216 is an FDA 510(k) clearance for the VIRAL ANTISERA, FLUORESCEIN LABELED, a Antiserum, Fluorescent, Mumps Virus (Class I — General Controls, product code GRA), submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977, 27 days after receiving the submission on February 2, 1977. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3380.

Submission Details

510(k) Number K770216 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1977
Decision Date March 01, 1977
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code GRA — Antiserum, Fluorescent, Mumps Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3380