Cleared Traditional

RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) (K770804) - FDA 510(k) Clearance

Class I Immunology device.

K770804 · Flow Laboratories, Inc. · Immunology device
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May 1977
Decision
17d
Days
Class 1
Risk

K770804 is an FDA 510(k) clearance for the RESP. SYNCYTIAL-FA LABELLHD (8-301-RF). Classified as Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (product code GQG), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1977 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3480 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Flow Laboratories, Inc. devices

Submission Details

510(k) Number K770804 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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 104d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3480
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GQG Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

All 31
Devices cleared under the same product code (GQG) and FDA review panel - the closest regulatory comparables to K770804.
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ABBOTT RSV EIA
K862429 · Abbott Laboratories · Sep 1986