Data / Medical devices / Japan / Medicatec Inc.
Medicatec Inc.: FDA-registered device maker in Yashio-shi Saitama, Japan, 1 510(k) clearance
Medicatec Inc. is registered with the FDA (registration 3013521527) in Yashio-shi Saitama, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013521527
- Address
- 1-11-28 Chuo, Yashio-shi Saitama, Japan, 340-0816
- Owner or operator
- Medicatec Inc. (10054577)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 12, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | 2 | 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 20, 2012 | K112910 | AP 72OS SEMI-AUTOMATED INSTRUMENT | DHB | Substantially Equivalent | Hitachi Chemical Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 20, 2012. 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.