# K962633: Vega Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abx, Inc.
- Decided: Nov 4, 1996 after 122 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TECHNICON H2 Hematology Analyzer: named in the summary without a submission number
- (no number) ABBOT CELL-DYN 3500 Hematology Analyzer: named in the summary without a submission number
- (no number) COULTER STKS Hematology Analyzer: named in the summary without a submission number

## Most influential descendants
- K990311: Vega Retic Automated Hematology Analyzer (1999), 4 descendants of its own
- K992511: Abx Pentra 60   Hematology Analyzer (1999), 3 descendants of its own
- K991839: Abx Pentra 120 Retic Automated Hematology Analyzer (1999), 3 descendants of its own
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (2002), 2 descendants of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own

## Indications for use
performing a twenty parameters hematological profile of whole blood specimens.

Source page: https://510kreport.com/device/K962633
Methodology: https://510kreport.com/methodology