Cleared Traditional

K832873 - MUMPS COMPLEMENT FIXATION & HEMAGGLU

K832873 is an FDA 510(k) clearance for MUMPS COMPLEMENT FIXATION & HEMAGGLU, manufactured by Hazleton Dutchland, Inc.. The device is a Class 1 Immunology device with product code GRC cleared through the Traditional 510(k) pathway after a 124-day FDA review.

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.

FDA 510(k) Submission Details - K832873

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 105d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

GRC Device Classification - Class 1, General Controls

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.

K832873 · MUMPS COMPLEMENT FIXATION & HEMAGGLU
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