# SENTINEL CH. SpA

- Location (FDA's records): Milan, IT
- FDA decisions: 22 (2005–2025): 22 510(k) clearances
- Names in FDA's records: SENTINEL CH. SpA (12); Sentinel Ch. Srl (10)
- Product codes: JIX (4), DCK (2), DEH (1), NDW (1), JIF (1), JFJ (1), DFH (1), JQF (1), CJW (1), JHS (1), NDY (1), JFY (1)
- Predicates its devices cite: 23 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Denka Seiken Co., Ltd.: 2 (https://510kreport.com/company/denka-seiken)
- Beckman Instruments, Inc.: 2 (https://510kreport.com/company/beckman-instruments)
- Trace America, Inc.: 2 (https://510kreport.com/company/trace-america)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- International Enzymes, Inc.: 1 (https://510kreport.com/company/international-enzymes)
- Quantimetrix Corp.: 1 (https://510kreport.com/company/quantimetrix)
- Boehringer Mannheim Corp.: 1 (https://510kreport.com/company/boehringer-mannheim)

## Its most-cited devices
- K050836: CRP Diagnostic Assay (2005), cited by 1
- K051452: Sentinel Clin Chem Cal (2005), cited by 1
- K051457: Sentinel Plasmaproteins Cal 3X (2005), cited by 1

## Recent decisions
- K242585: Cystatin C (May 16, 2025)
- K211058: Lp (a) Ultra (Dec 22, 2022)
- K193001: Albumin BCP (Dec 19, 2019)
- K192118: CRP Vario (Nov 8, 2019)
- K173833: CRP Vario (Sep 27, 2018)
- K141728: Ace Calibrator (Jul 28, 2014)
- K102706: CKMB Udr Assay (Aug 19, 2011)
- K083602: Kappa Light Chains (Sep 3, 2009)

Source page: https://510kreport.com/company/sentinel-ch