Cleared Traditional

K962633 - VEGA HEMATOLOGY ANALYZER

K962633 is an FDA 510(k) clearance for VEGA HEMATOLOGY ANALYZER, manufactured by Abx, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K962633 · Abx, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
122d
Days
Class 2
Risk

K962633 is an FDA 510(k) clearance for the VEGA HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abx, Inc. (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on November 4, 1996 after a review of 122 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 Abx, Inc. devices

FDA 510(k) Submission Details - K962633

510(k) Number K962633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1996
Decision Date November 04, 1996
Days to Decision 122 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
9d slower than avg
Panel avg: 113d · This submission: 122d
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 303
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K962633.
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
K964618 · Coulter Corp. · Dec 1996
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
K963963 · Becton Dickinson Immunocytometry Systems · Dec 1996
CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
K963954 · Caltag Laboratories, Inc. · Nov 1996
ABBOTT CELL-DYN 4000 SYSTEM
K961439 · Abbott Diagnostics · Oct 1996
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955715 · Abbott Laboratories · Oct 1996
RETICULOCYTE METHOD, RBC INDICES
K954594 · Bayer Corp. · Aug 1996