Cleared Traditional

MUMPS COMPLEMENT FIXATION & HEMAGGLU (K832873) - FDA 510(k) Clearance

Class I Immunology device.

K832873 · Hazleton Dutchland, Inc. · Immunology device
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Dec 1983
Decision
124d
Days
Class 1
Risk

K832873 is an FDA 510(k) clearance for the MUMPS COMPLEMENT FIXATION & HEMAGGLU. Classified as Antigen, Cf (including Cf Control), Mumps Virus (product code GRC), Class I - General Controls.

Submitted by Hazleton Dutchland, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 124 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.

View all Hazleton Dutchland, Inc. devices

Submission Details

510(k) Number K832873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1983
Decision Date December 27, 1983
Days to Decision 124 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 104d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GRC Antigen, Cf (including Cf Control), 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.