Vega Hematology Analyzer

FDA 510(k) K962633 · Abx, Inc.

Substantially Equivalent

510(k) numberK962633

Submission

Device name
Vega Hematology Analyzer
Applicant
Abx, Inc.
Montpellier Cedex 4, FR
Received
July 5, 1996
Decision date
November 4, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GKZ – Counter, Differential Cell
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5220
Specialty
Hematology

Other 510(k)s with product code GKZ

510(k)DeviceApplicantDecision
K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional Sysmex America, Inc.05/27/2026SE
K243348Athelas HomeGKZ · Traditional Athelas, Inc.02/06/2026SE
K251249Tru Hematology TestGKZ · Traditional Truvian Sciences, Inc.01/16/2026SE
K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional Sysmex America, Inc.06/25/2025SE
K243283Alinity h-series SystemGKZ · Traditional Abbott Laboratories02/20/2025SE
K240402Cito CBC SystemGKZ · Dual Track Cytochip, Inc.02/03/2025SE
K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional Beckman Coulter, Inc.07/05/2024SE
K232946Yumizen H2500GKZ · Traditional Horiba Abx SAS05/21/2024SE
K240636HemoScreen Hematology AnalyzerGKZ · Abbreviated Pixcell Medical Technologies05/02/2024SE

More from Pixcell Medical Technologies

510(k)DeviceDecision
K895127ArgosGKZ · Traditional 10/10/1989SE
K880616Minos Automatic Cell CounterGKZ · Traditional 05/02/1988SE
K864579Minos Automatic Cell CounterGKZ · Traditional 07/16/1987SE

Questions and answers

When was Vega Hematology Analyzer cleared by the FDA?

Vega Hematology Analyzer (K962633) received a 510(k) decision of Substantially Equivalent on November 4, 1996, 122 days after the submission was received.

What is the product code of K962633?

The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.