# K973634: Coulter AC.T Diff Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Oct 29, 1997 after 35 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: 2 generations back to K823355 (1982). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964988: Coulter AC.T Series Analyzer, Coulter Corp. (1997) Summary page 1.
- K823355: Coulter-Counter #S Plus IV & Lyse S +D, Coulter Electronics, Inc. (1982) Summary page 1.

## Most influential descendants
- K990352: Coulter AC T Diff 2 Analyzer (1999), 3 descendants of its own
- K093394: BC-3200 Auto Hematology Analyzer,M-30D Diluent, M-30R Rinse, M-30CFL Lyse, M-30E-Z Cleanser, M-30PROBE Cleanser, BC-3D C (2010), 1 descendant of its own
- K143348: BC-3600 Auto Hematology Analyzer (2015), 0 descendants of its own
- K063407: BC-3200 Auto Hematology Analyzer (2007), 0 descendants of its own

## Indications for use
The COULTER® AC-T diff™ analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

Source page: https://510kreport.com/device/K973634
Methodology: https://510kreport.com/methodology