Cleared Traditional

WELLCOGEN H. INFLUENZAL ZL21 (K833077) - FDA 510(k) Clearance

Class I Immunology device.

K833077 · Wellcome Diagnostics · Immunology device
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Jan 1984
Decision
123d
Days
Class 1
Risk

K833077 is an FDA 510(k) clearance for the WELLCOGEN H. INFLUENZAL ZL21. Classified as Antiserum, Hai, Mumps Virus (product code GRD), Class I - General Controls.

Submitted by Wellcome Diagnostics (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3380 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K833077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1983
Decision Date January 10, 1984
Days to Decision 123 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 104d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GRD Antiserum, Hai, Mumps Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3380
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.