Cleared Traditional

K964856 - CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOC...

K964856 is the FDA 510(k) clearance for CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOC... by Caltag Laboratories, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K964856 · Caltag Laboratories, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jan 1997
Decision
44d
Days
Class 2
Risk

K964856 is an FDA 510(k) clearance for the CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Caltag Laboratories, Inc. (Dowingtown, US). The FDA issued a Cleared decision on January 17, 1997 after a review of 44 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 Caltag Laboratories, Inc. devices

Submission Details

510(k) Number K964856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date January 17, 1997
Days to Decision 44 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
69d faster than avg
Panel avg: 113d · This submission: 44d
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 194
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