# Kamiya Biomedical Co.

- Location (FDA's records): Seattle, WA
- FDA decisions: 46 (1991–2025): 46 510(k) clearances
- Names in FDA's records: Kamiya Biomedical Co. (43); Kamiya Biomedical Company (2); Kamiya Biomedical Company, LLC (1)
- Product codes: DCK (9), DHR (4), DBF (3), JIX (3), DAP (2), DFC (2), CFF (2), JJY (2), DER (2), DEW (1), GIS (1), DBA (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 10 (2 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
- Gilford: 3 (https://510kreport.com/company/gilford)

## Firms that cite its devices most
- Diazyme Laboratories: 2 (https://510kreport.com/company/diazyme-laboratories)
- Good Biotech Corp.: 2 (https://510kreport.com/company/good-biotech)
- Horiba Abx: 2 (https://510kreport.com/company/horiba-abx)
- General Atomics: 1 (https://510kreport.com/company/general-atomics)
- Alfa Wassermann Diagnostic Technologies, Inc.: 1 (https://510kreport.com/company/alfa-wassermann-diagnostic-technologies)

## Its most-cited devices
- K023828: K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP Multi-Calibrator E, K-Assay CRP Multi-Calibr (2003), cited by 3
- K050944: K-Assay Ferritin (2) & Ferritin Calibrator Set (2005), cited by 2
- K993482: K-Assay Fibrinogen (1999), cited by 1
- K992311: K-Assay CRP (1), K-Assay CRP Multi-Calibrator a, K-Assay CRP Multi-Calibratorc (1999), cited by 1
- K022486: K-Assay HS-CRP Controls (2002), cited by 1
- K993345: K-Assay Apo AI (1999), cited by 1

## Recent decisions
- K242170: K-ASSAY CRP (Ver.2) (Apr 18, 2025)
- K192727: K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (May 20, 2020)
- K121232: K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin Calibrator (May 24, 2012)
- K093137: K-Assay Cystatin C Reagent, Calibrator and Control (Sep 28, 2010)
- K091486: K-Assay Microalbumin and K-Assay Microalbumin Calibrator (Apr 29, 2010)
- K050944: K-Assay Ferritin (2) & Ferritin Calibrator Set (Dec 23, 2005)
- K042241: K-Assay Total Ige, K-Assay Ige Calibrator Set, Models Kai-092/Kai-093C (Dec 10, 2004)
- K030687: K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models Kai-090; Kaj-091C (Jun 27, 2003)

Source page: https://510kreport.com/company/kamiya-biomedical