Cleared Traditional

K924395 - NEOTHROMITIN(R)

K924395 is an FDA 510(k) clearance for NEOTHROMITIN, manufactured by Behring Diagnostics, Inc.. The device is a Class 1 Hematology device with product code GPO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K924395

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

GPO Device Classification - Class 1, General Controls

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.