Cleared Traditional

BEHRING NEPHELOMETER 100 (K892223) - FDA 510(k) Clearance

Class I Immunology device.

K892223 · Behring Diagnostics, Inc. · Immunology device
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May 1989
Decision
31d
Days
Class 1
Risk

K892223 is an FDA 510(k) clearance for the BEHRING NEPHELOMETER 100. Classified as Nephelometer (product code JZW), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on May 4, 1989 after a review of 31 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 K892223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date May 04, 1989
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 104d · This submission: 31d
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.