# K954688: Flow-Count Coulter Fluorospheres

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Feb 29, 1996 after 141 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- May 21, 2007 · Not classified · Z-0525-2008: Sporadic absolute count recovery failures with assayed control cell products when using Lot Number 754801F of the Flow-Count Fluorospheres. Additionally, this lot has experienced secondary fluorescent

Source page: https://510kreport.com/device/K954688
Methodology: https://510kreport.com/methodology