Cleared Traditional

ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. (K761236) - FDA 510(k) Clearance

Class I Immunology device.

K761236 · Behring Diagnostics, Inc. · Immunology device
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Dec 1976
Decision
20d
Days
Class 1
Risk

K761236 is an FDA 510(k) clearance for the ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.. Classified as Nephelometer (product code JZW), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4540 - 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K761236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1976
Decision Date December 30, 1976
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZW Nephelometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4540
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.