Data / Medical devices / Japan / Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant
Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant: FDA-registered device maker in Izunokuni-shi Shizuoka, Japan, 1 510(k) clearance
Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant is registered with the FDA (registration 8043889) in Izunokuni-shi Shizuoka, 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
- 8043889
- FEI number
- 3003206796
- Address
- 632-1 Mifuku, Izunokuni-shi Shizuoka, Japan, 410-2321
- Owner or operator
- Nagase Diagnostics Co., Ltd. (10059378)
- Roles
- Manufacturer
- First device listed
- December 28, 2018
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | 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 |
|---|---|---|---|---|---|---|
| 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 Assay, Glycosylated Hemoglobin
- All makers of Calibrator, Secondary
- 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.