# K961610: R & D Systems' Whole Blood Flow Control, (R & D - WBFC)

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Jul 1, 1996 after 67 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 K920997 (1992). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920997: CD-Chex, Streck Laboratories, Inc. (1992) Summary page 1.

## Most influential descendants
- K982231: Statusflow (1998), 1 descendant of its own
- K150815: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (2015), 0 descendants of its own

## Indications for use
R&D Systems’ Whole Blood Flow Control (WBFC) is a stabilized preparation of human peripheral leukocytes and erythrocytes to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance.

Source page: https://510kreport.com/device/K961610
Methodology: https://510kreport.com/methodology