Data / Medical devices / Japan / Nagase Diagnostics Co., Ltd.
Nagase Diagnostics Co., Ltd.: FDA-registered device maker in Chuo-ku Tokyo, Japan, 1 510(k) clearance
Nagase Diagnostics Co., Ltd. is registered with the FDA (registration 3003460426) in Chuo-ku Tokyo, Japan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 12, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003460426
- Address
- 12-15, Nihonbashi-Kobunacho, Chuo-ku Tokyo, Japan, 103-0024
- Owner or operator
- Nagase Diagnostics Co., Ltd. (10059378)
- Roles
- Complaint file establishment
- First device listed
- December 28, 2018
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | 2 | Complaint file establishment | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Complaint file establishment | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| October 12, 2017 | K170147 | Lucica Glycated Albumin-L | LCP | Substantially Equivalent | Asahi Kasei Pharma Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Secondary
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated October 12, 2017. 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.