Data / Medical devices / Japan / Hamamatsu Photonics Electron Tube Division
Hamamatsu Photonics Electron Tube Division: FDA-registered device maker in Iwata City Shizuoka, Japan, 1 510(k) clearance
Hamamatsu Photonics Electron Tube Division is registered with the FDA (registration 3005586126) in Iwata City Shizuoka, Japan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 17, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005586126
- Address
- 314-5, Shimokanzo, Iwata City Shizuoka, Japan, 438-0193
- Owner or operator
- HAMAMATSU PHOTONICS ELECTRON TUBE DIVISION (10061112)
- Roles
- Manufacturer
- First device listed
- August 23, 2019
- Registered through
- 2026
- Brand names listed
- Acucy System; Part Number 1039
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | 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 |
|---|---|---|---|---|---|---|
| December 17, 2018 | K182001 | Acucy Influenza A&B Test with the Acucy System | PSZ | Substantially Equivalent | SEKISUI Diagnostics, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 17, 2018. 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.