Data / Medical devices / Japan / Shima Laboratories Co., Ltd.
Shima Laboratories Co., Ltd.: FDA-registered device maker in ITABASHI-KU Tokyo, Japan, 2 510(k) clearances
Shima Laboratories Co., Ltd. is registered with the FDA (registration 3003985394) in ITABASHI-KU Tokyo, Japan. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 10, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003985394
- Address
- 3-36-3, Maeno-Cho, ITABASHI-KU Tokyo, Japan, 1740063
- Owner or operator
- SHIMA LABORATORIES CO., LTD. (9055348)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 18, 2008
- Registered through
- 2026
- Brand names listed
- D-Dimer control, D-Dimer reagent, INSULIN Reagent, IgE Control, IgE reagent, Insulin Control
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Secondary | JIT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Fibrin Split Products | GHH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ige, Antigen, Antiserum, Control | DGC | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Immunoreactive Insulin | CFP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 10, 2004 | K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | DGC | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| June 27, 2003 | K030687 | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C | DAP | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Calibrator, Secondary
- All makers of Ige, Antigen, Antiserum, Control
- All makers of Radioimmunoassay, Immunoreactive Insulin
- All makers of Plasma, Coagulation Control
- All makers of Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Updated December 10, 2004. 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.