# K990352: Coulter AC T Diff 2 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Apr 1, 1999 after 55 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K823355 (1982). 3 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K973634: Coulter AC.T Diff 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
- 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

## Recalls of this device
- Dec 3, 2004 · Not classified · Z-0339-05: Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not

## Indications for use
The COULTER® AC-T diff 2™ 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/K990352
Methodology: https://510kreport.com/methodology