Cleared Traditional

K770805 - MEASLES-FA LABELLED (8-441 RF)

K770805 is the FDA 510(k) clearance for MEASLES-FA LABELLED (8-441 RF) by Flow Laboratories, Inc.. It is a Class 2 Immunology device (product code GOL) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K770805 · Flow Laboratories, Inc. · Immunology device
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May 1977
Decision
17d
Days
Class 2
Risk

K770805 is an FDA 510(k) clearance for the MEASLES-FA LABELLED (8-441 RF). Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special 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 866.3510 - 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 K770805 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 104d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GOL Antigen, Ha (including Ha Control), Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - GOL Antigen, Ha (including Ha Control), Rubella

All 12
Devices cleared under the same product code (GOL) and FDA review panel - the closest regulatory comparables to K770805.
CORDIA T
K790212 · Cordis Corp. · Apr 1979
CORDIA R
K780885 · Cordis Corp. · Jan 1979
RUBA-NOST TEST KITS
K771796 · Behring Diagnostics, Inc. · Oct 1977
MEASLES-FA LABELED PRESERUM (8-441 RNF)
K770809 · Flow Laboratories, Inc. · May 1977
TEST FOR DETECTION OF ANTIRUBELLA ANTIB
K760889 · Abbott Laboratories · Nov 1976