Cleared Traditional

MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (K852932) - FDA 510(k) Clearance

Class I Immunology device.

K852932 · Microbix Biosystems, Inc. · Immunology device
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Nov 1985
Decision
126d
Days
Class 1
Risk

K852932 is an FDA 510(k) clearance for the MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT. Classified as Antiserum, Cf, Rubeola (product code GRF), Class I - General Controls.

Submitted by Microbix Biosystems, Inc. (Canada, CA). The FDA issued a Cleared decision on November 12, 1985 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3520 - 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 Microbix Biosystems, Inc. devices

Submission Details

510(k) Number K852932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date November 12, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 104d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GRF Antiserum, Cf, Rubeola
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3520
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.