# R&D Systems, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 79 (1978–2016): 79 510(k) clearances
- Product codes: JPK (45), KRX (4), KSA (3), GGM (3), JCN (3), GGT (3), GKZ (2), KQC (2), GKR (1), KJN (1), LIB (1), JNM (1)
- Predicates its devices cite: 28 (18 its own); citations of its devices by later devices: 32 (18 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Streck Laboratories, Inc.: 4 (https://510kreport.com/company/streck-laboratories)
- Medical Specialties Intl., Inc.: 2 (https://510kreport.com/company/medical-specialties-intl)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)
- Bayer Diagnostics Corp.: 1 (https://510kreport.com/company/bayer-diagnostics)
- Quantimetrix Corp.: 1 (https://510kreport.com/company/quantimetrix)
- Streck: 1 (https://510kreport.com/company/streck)

## Firms that cite its devices most
- Beckman Coulter, Inc.: 3 (https://510kreport.com/company/beckman-coulter)
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Fertility Solutions, Inc.: 2 (https://510kreport.com/company/fertility-solutions)
- Haemoscope Corp.: 1 (https://510kreport.com/company/haemoscope)
- Nichols Institute Diagnostics: 1 (https://510kreport.com/company/nichols-institute-diagnostics)
- Mentor Corp.: 1 (https://510kreport.com/company/mentor)
- Ramco Laboratories, Inc.: 1 (https://510kreport.com/company/ramco-laboratories)
- Streck Laboratories, Inc.: 1 (https://510kreport.com/company/streck-laboratories)

## Its most-cited devices
- K970718: Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa) (1997), cited by 4
- K904464: CBC-Laser (R) Hematology Control/Multiple-Modified (1990), cited by 2
- K961610: R & D Systems' Whole Blood Flow Control, (R & D - WBFC) (1996), cited by 2
- K942822: CBC-Line Hematology Linearity Control (1994), cited by 2
- K954137: QBC Centrifugal Hematology Control (1995), cited by 2
- K042094: R&D CBC-XE Hematology Control (2004), cited by 2

## Recent decisions
- K160606: BC-5D Hematology Control (Sep 1, 2016)
- K130962: R&D 5D Retic Hematology Control (Jul 24, 2013)
- K101578: R&D Systems Body Fluid-I Hematology Control (Apr 28, 2011)
- K100050: R & D Systems Xeret Hematology Control (Jan 29, 2010)
- K091433: R&D Systems Tetic-I Plus Hemotology Control (Oct 28, 2009)
- K073178: HCT Extended Hematology Control, Model HCT004 (Dec 27, 2007)
- K072846: CSF Automated Control, Models CSF001, CSF003 (Nov 26, 2007)
- K072268: HC WBC Hematology Control, Model: WBC00S (Nov 20, 2007)

Source page: https://510kreport.com/company/r-d-systems