# Beckman Coulter, Inc.

- Location (FDA's records): Brea, CA
- FDA decisions: 286 (1986–2026): 280 510(k) clearances, 1 De Novo grant and 5 original PMA approvals
- Names in FDA's records: Beckman Coulter, Inc. (278); Beckman Coulter (8)
- Product codes: GKZ (28), LTT (12), MMI (10), JPK (10), JJX (9), JIT (8), LGD (7), JIS (6), JJY (6), MSW (5), OYE (5), CGN (5)
- 510(k) review time since 2016: median 161 days, against 145 for FDA's reviews in the same codes and years (12 of 32 faster)
- Predicates its devices cite: 292 (150 its own); citations of its devices by later devices: 213 (150 its own)
- Recalls linked to its devices: 316 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Beckman Instruments, Inc.: 29 (https://510kreport.com/company/beckman-instruments)
- Bio-Rad Laboratories, Inc.: 18 (https://510kreport.com/company/bio-rad-laboratories)
- Abbott Laboratories: 10 (https://510kreport.com/company/abbott-laboratories)
- Coulter Corp.: 9 (https://510kreport.com/company/coulter)
- Olympus America, Inc.: 6 (https://510kreport.com/company/olympus-america)
- Coulter Electronics, Inc.: 6 (https://510kreport.com/company/coulter-electronics)
- Dade Behring, Inc.: 5 (https://510kreport.com/company/dade-behring)
- Roche Diagnostics Corp.: 5 (https://510kreport.com/company/roche-diagnostics)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 7 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Dade Behring, Inc.: 5 (https://510kreport.com/company/dade-behring)
- Roche Diagnostics Corp.: 4 (https://510kreport.com/company/roche-diagnostics)
- Beckman Coulter Biomedical GmbH: 4 (https://510kreport.com/company/beckman-coulter-biomedical)
- Abbott Point of Care, Inc.: 3 (https://510kreport.com/company/abbott-point-of-care)
- Pointcare Technologies, Inc.: 3 (https://510kreport.com/company/pointcare-technologies)
- Horiba, Ltd.: 2 (https://510kreport.com/company/horiba)
- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.: 2 (https://510kreport.com/company/beckman-coulter-laboratory-systems-suzhou)

## Its most-cited devices
- K011342: Coulter LH 750 Hematology Analyzer, Model 6605632 (2001), cited by 8
- K042291: Unicel DXC 600 and 800 Synchron Systems (2004), cited by 6
- K011213: Modification to Synchron LX 20 Clinical Chemistry System (2001), cited by 5
- K140911: Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System (2014), cited by 5
- K060774: Folate on the Access Immunoassay Systems, Model A14208 (2006), cited by 4
- K030606: Coulter LH 750 Body Fluids Application (2003), cited by 4

## Recent decisions
- K262597: Access BNP II (Oct 20, 2026)
- K261109: Access MeMed BV (Oct 19, 2026)
- K262109: Access NT-proBNP (Sep 21, 2026)
- K252169: Access BNP II (Mar 24, 2026)
- K254059: Access anti-HBc IgM (Mar 13, 2026)
- K253687: Access anti-HBc Total (Feb 19, 2026)
- K251995: Access anti-HAV IgM (Jan 27, 2026)
- K250588: Access Rubella IgG (Nov 17, 2025)

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