Cleared Traditional

K770807 - ADENOVIRUS-GROUP FA LABELLED (8-651 RF)
(FDA 510(k) Clearance)

K770807 · Flow Laboratories, Inc. · Immunology device
May 1977
Decision
17d
Days
Class 1
Risk

K770807 is an FDA 510(k) clearance for the ADENOVIRUS-GROUP FA LABELLED (8-651 RF). This device is classified as a Antisera, Fluorescent, Adenovirus 1-33 (Class I - General Controls, product code GNY).

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1977, 17 days after receiving the submission on May 3, 1977.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K770807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1977
Decision Date May 20, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code GNY — Antisera, Fluorescent, Adenovirus 1-33
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.3020