Data / Medical devices / Japan / Kikuyo Factory
Kikuyo Factory: FDA-registered device maker in Kumamoto, Japan, 1 510(k) clearance
Kikuyo Factory is registered with the FDA (registration 3015969360) in Kumamoto, Japan. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 16, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015969360
- Address
- 1552-1 Aza Kazaawa, Oaza Magate, Kikuyo-machi, Kikuchi-gun, Kumamoto, Japan, 869-1106
- Owner or operator
- IDS CO, LTD (10049986)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 25, 2015
- Registered through
- 2026
- Brand names listed
- IDS-CLAS Compact S1 - DK01, DY01, DW01, DH02, DH03, DH04, DM01, DR01, DJ01, DJ02, DU01, DT01, DS01, DC01, Power Express, cobas BLIM for p471/p671/BCM, cobas BLIM for p512/p612
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Folic, Radioimmunoassay | CGN | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ferritin, Antigen, Antiserum, Control | DBF | 2 | Manufacturer | accessdata.fda.gov |
| Radioassay, Vitamin B12 | CDD | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2014 | K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents | CDD | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Radioimmunoassay, Thyroid-Stimulating Hormone
- All makers of Acid, Folic, Radioimmunoassay
- All makers of Radioassay, Vitamin B12
- All makers of Ferritin, Antigen, Antiserum, Control
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Calculator/Data Processing Module, For Clinical Use
Updated September 16, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.