Cleared Traditional

K961435 - MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961435 · Dako Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
60d
Days
Class 2
Risk

K961435 is an FDA 510(k) clearance for the MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN 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 60 days - a notably fast clearance cycle.

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: 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 Dako Corp. devices

Submission Details

510(k) Number K961435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date June 14, 1996
Days to Decision 60 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
53d faster than avg
Panel avg: 113d · This submission: 60d
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 378
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K961435.
Athelas Home
K243348 · Athelas, Inc. · Feb 2026
Tru Hematology Test
K251249 · Truvian Sciences, Inc. · Jan 2026
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
K250943 · Sysmex America, Inc. · Jun 2025
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
K251371 · Sysmex America, Inc. · Jun 2025
Alinity h-series System
K243283 · Abbott Laboratories · Feb 2025
Cito CBC System
K240402 · Cytochip, Inc. · Feb 2025