# Randox Laboratories, Ltd.

- Location (FDA's records): Crumlin, GB
- FDA decisions: 134 (1992–2026): 133 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Randox Laboratories, Ltd. (116); Randox Laboratories Limited (18)
- Product codes: JJY (15), JJX (5), DJG (5), JIX (5), DJR (3), DCK (3), JIS (3), CGS (3), LBS (3), DIS (2), JXM (2), KHS (2)
- 510(k) review time since 2016: median 492 days, against 140 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 30 (10 its own); citations of its devices by later devices: 28 (10 its own)
- Recalls linked to its devices: 86 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Rad Laboratories, Inc.: 3 (https://510kreport.com/company/bio-rad-laboratories)
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Bayer Corp.: 2 (https://510kreport.com/company/bayer)
- Medtox Diagnostics, Inc.: 2 (https://510kreport.com/company/medtox-diagnostics)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Lin-Zhi International, Inc.: 1 (https://510kreport.com/company/lin-zhi-international)
- Bio-Rad, Diagnostics Grp.: 1 (https://510kreport.com/company/bio-rad-diagnostics-grp)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 6 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Polymedco, Inc.: 2 (https://510kreport.com/company/polymedco)
- Siemens Medical Solutions Diagnostics: 2 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)
- Good Biotech Corp.: 1 (https://510kreport.com/company/good-biotech)
- Immunalysis Corporation: 1 (https://510kreport.com/company/immunalysis)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Axis-Shield Poc AS: 1 (https://510kreport.com/company/axis-shield-poc)

## Its most-cited devices
- K023763: Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls (2003), cited by 3
- K982341: Direct HDL-Cholestrol Liquid (1998), cited by 3
- K052914: RX Imola (2006), cited by 2
- K022682: Randox C-Reactive Protein Calibrator (2002), cited by 2
- K061056: Randox Liquid Protein Calibrator (2006), cited by 2
- K923504: Cholesterol Enzymatic Endpoint (1994), cited by 1

## Recent decisions
- K250741: Evidence MultiSTAT DOA Urine MultiPlex (Jan 23, 2026)
- DEN240035: ConcizuTrace™ ELISA (May 22, 2025)
- K221550: Evidence MultiSTAT DOA Urine MultiPlex (Oct 5, 2023)
- K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (Oct 5, 2023)
- K230890: ISE Electrodes (Sep 8, 2023)
- K182042: Randox Calcium (Ca) (Oct 23, 2018)
- K162200: Randox RX Daytona Plus Magnesium (MG) (Apr 28, 2017)
- K162275: Randox RX Daytona Plus Alkaline Phosphatase (ALP) (Apr 21, 2017)

Source page: https://510kreport.com/company/randox-laboratories