Cleared Traditional

K963954 - CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY

K963954 is an FDA 510(k) clearance for CD 19 R-PE, manufactured by Caltag Laboratories, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K963954 · Caltag Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
54d
Days
Class 2
Risk

K963954 is an FDA 510(k) clearance for the CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY. 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 November 25, 1996 after a review of 54 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

FDA 510(k) Submission Details - K963954

510(k) Number K963954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1996
Decision Date November 25, 1996
Days to Decision 54 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
59d faster than avg
Panel avg: 113d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K963954.
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