# K913192: Simultest (TM) Imk-Lymphocyte

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Feb 6, 1992 after 203 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.
16 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970326: Tritest Reagent CD3 Fitc/CD8 PE/CD45 Percp;with Trucount Absolute Count Tubes (1997), 11 descendants of its own
- K970836: Trucount Absolute Count Tubes/Counting Control Beads (1997), 11 descendants of its own
- K974360: Multitest CD3/CD8/CD45/CD4 (1998), 10 descendants of its own
- K971110: Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 Percp;with Trucount Absolute Count Tubes (1997), 6 descendants of its own
- K970742: Tritest CD3 Fitc/CD19 PE/CD45 Percp Reagent with Trucount Absolute Count Tubes (1997), 6 descendants of its own

Source page: https://510kreport.com/device/K913192
Methodology: https://510kreport.com/methodology