Cleared Traditional

K960531 - MOUSE ANTI-HUMAN CD3

K960531 is the FDA 510(k) clearance for MOUSE ANTI-HUMAN CD3 by Dako Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K960531 · Dako Corp. · Hematology device
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Jun 1996
Decision
128d
Days
Class 2
Risk

K960531 is an FDA 510(k) clearance for the MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on June 14, 1996 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Dako Corp. devices

Submission Details

510(k) Number K960531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1996
Decision Date June 14, 1996
Days to Decision 128 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
15d slower than avg
Panel avg: 113d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K960531.
COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
K961278 · Coulter Corp. · Jul 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
K961701 · Dako Corp. · Jul 1996
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
K961610 · R&D Systems, Inc. · Jul 1996
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
K961435 · Dako Corp. · Jun 1996
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955673 · Abbott Laboratories · May 1996
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
K960887 · Dako Corp. · May 1996