# Diamond Diagnostics, Inc.

- Location (FDA's records): Holliston, MA
- FDA decisions: 26 (2001–2020): 26 510(k) clearances
- Product codes: JIT (9), JJY (6), JGS (4), CEM (2), JIX (1), CDS (1), CGX (1), JJS (1), CGA (1)
- Predicates its devices cite: 36 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Beckman-Diagnostic Systems Group: 4 (https://510kreport.com/company/beckman-diagnostic-systems-group)
- Beckman Instruments, Inc.: 4 (https://510kreport.com/company/beckman-instruments)
- Medica Corp.: 4 (https://510kreport.com/company/medica)
- Avl Scientific Corp.: 4 (https://510kreport.com/company/avl-scientific)
- Corning Medical & Scientific: 3 (https://510kreport.com/company/corning-medical-scientific)
- Ciba Corning Diagnostics Corp.: 3 (https://510kreport.com/company/ciba-corning-diagnostics)
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)
- Tokyo Boeki Medical System, Ltd.: 1 (https://510kreport.com/company/tokyo-boeki-medical-system)

## Its most-cited devices
- K082462: Gemlyte Electrolyte Analyzer NA+/K+/CL-/CA++/LI+ (2009), cited by 2
- K070104: Prolyte Electrolyte Analyzer (2008), cited by 1
- K103364: Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level (2011), cited by 1
- K093492: Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical Calibrator (2010), cited by 1
- K121027: Diamond Calibrator Low, Diamond Calibrator High (2012), cited by 1

## Recent decisions
- K200544: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (Oct 1, 2020)
- K133751: Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards (Aug 8, 2014)
- K124009: Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level 2, Mission C (Apr 17, 2013)
- K121027: Diamond Calibrator Low, Diamond Calibrator High (Dec 20, 2012)
- K121040: Smartlyte Electrolyte Analyzer (Aug 30, 2012)
- K121140: Prolyte Electrolyte Analyzer (Aug 22, 2012)
- K120591: Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2 (Apr 17, 2012)
- K103364: Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level (May 6, 2011)

Source page: https://510kreport.com/company/diamond-diagnostics