Cleared Traditional

K960887 - MOUSE ANTI-HUMAN CD4

K960887 is the FDA 510(k) clearance for MOUSE ANTI-HUMAN CD4 by Dako Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K960887 · Dako Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
74d
Days
Class 2
Risk

K960887 is an FDA 510(k) clearance for the MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/C.... 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 May 17, 1996 after a review of 74 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 K960887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date May 17, 1996
Days to Decision 74 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
39d faster than avg
Panel avg: 113d · This submission: 74d
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 K960887.
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
K960531 · Dako Corp. · Jun 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
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
K950568 · Ortho Diagnostic Systems, Inc. · May 1996
ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
K950625 · Ortho Diagnostic Systems, Inc. · May 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
K951100 · Ortho Diagnostic Systems, Inc. · May 1996