# K953598: Series 9100 Plus Automated Differential Hematology Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Serono Diagnostics, Inc.
- Decided: Mar 11, 1996 after 223 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
Longest line of descent: 1 generation back to K870603 (1987). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911626: System 9000, Interpretive Diff Cell Counter, Serono Baker Diagnostics System (1991) Summary page 3.
- K870603: System 9000 Automated Cell Counter, Baker Instructions Corp. (1987) Summary page 3.

## Most influential descendants
- 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
- K151133: Pentra XLR (2015), 0 descendants of its own

## Indications for use
Each of the four models within the Series 9100+ PLUS (i.e., Model 9120, Model 9118, Model 9110, and Model 9100 Rx) is intended for use as a fully automated hematology cell counter for the in vitro diagnostic testing of whole blood specimens. The Series 9100+ PLUS also is intended to flag or identify specimens containing abnormal blood cells.

Source page: https://510kreport.com/device/K953598
Methodology: https://510kreport.com/methodology