# Coulter Electronics, Inc.

- Location (FDA's records): Hialeah, FL
- FDA decisions: 101 (1976–1994): 101 510(k) clearances
- Product codes: GKL (17), GKZ (14), JPK (8), CIT (4), CKA (4), JJE (3), KRY (3), CDT (3), JHT (2), CIJ (2), CHH (2), JCE (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 16 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Coulter Corp.: 6 (https://510kreport.com/company/coulter)
- Beckman Coulter, Inc.: 6 (https://510kreport.com/company/beckman-coulter)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Ortho Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/ortho-diagnostic-systems)
- Cdc Technologies, Inc.: 1 (https://510kreport.com/company/cdc-technologies)
- Hematronix, Inc.: 1 (https://510kreport.com/company/hematronix)

## Its most-cited devices
- K885093: Coulter STKS (1988), cited by 4
- K823355: Coulter-Counter #S Plus IV & Lyse S +D (1982), cited by 4
- K912133: PX Coulter (R) Cell Control (1991), cited by 3
- K813375: Hematology Calibrator S-Cal (1982), cited by 1
- K922704: Coulter Maxm W/ Autoloader (1992), cited by 1
- K874188: Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta (1988), cited by 1

## Recent decisions
- K923951: CD8 Cytospheres Kit (Apr 25, 1994)
- K930119: Coulter Retic-C Cell Control (Apr 5, 1993)
- K921279: CD4 Cytospheres Kit (Dec 29, 1992)
- K923530: Coulter Multi-Q-Prep (Oct 14, 1992)
- K922181: Coulter MH009 (Aug 17, 1992)
- K922704: Coulter Maxm W/ Autoloader (Jul 27, 1992)
- K921567: Coulter MH017 (Jul 6, 1992)
- K912133: PX Coulter (R) Cell Control (Jul 17, 1991)

Source page: https://510kreport.com/company/coulter-electronics