Cleared Traditional

NEOTHROMITIN(R) (K924395) - FDA 510(k) Clearance

Class I Hematology device.

K924395 · Behring Diagnostics, Inc. · Hematology device
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Dec 1992
Decision
92d
Days
Class 1
Risk

K924395 is an FDA 510(k) clearance for the NEOTHROMITIN(R). Classified as Antigen, Cf, Typhus Fever Group (product code GPO), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.3500 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K924395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date December 01, 1992
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GPO Antigen, Cf, Typhus Fever Group
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3500
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.