Data / Medical devices / Japan / Tosoh Hi-Tec, Inc.
Tosoh Hi-Tec, Inc.: FDA-registered device maker in Yamaguchi, Japan, 3 510(k) clearances
Tosoh Hi-Tec, Inc. is registered with the FDA (registration 3004529019) in Yamaguchi, Japan. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004529019
- Address
- 1-37 Fukugawa Minami-machi Shunan-shi, Yamaguchi, Japan, 746-0042
- Owner or operator
- TOSOH BIOSCIENCE (8031673)
- Roles
- Manufacturer
- First device listed
- November 14, 2005
- Registered through
- 2026
- Brand names listed
- AIA®-CL1200 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER, AIA®-CL2400 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER, AIA®-CL300 AUTOMATED CHEMILUMINESCENT ENZYME IMMUNOASSAY ANALYZER, Automated Immunoassay Analyzer AIA-2000, Automated Immunoassay Analyzer AIA-360, Automated Immunoassay Analyzer AIA-900, F and A2 Calibrator Set 2, G11 90 SL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Primary | JIS | 2 | Manufacturer | accessdata.fda.gov |
| Fluorometer, For Clinical Use | KHO | 1 | Manufacturer | accessdata.fda.gov |
| Hemoglobin A1c Test System | PDJ | 2 | Manufacturer | accessdata.fda.gov |
| Hemoglobin A2 Quantitation | JPD | 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 3, 2025 | K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | PDJ | Substantially Equivalent | Tosoh Bioscience, Inc. | accessdata.fda.gov |
| September 16, 2008 | K071132 | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 | LCP | Substantially Equivalent | Tosoh Bioscience, Inc. | accessdata.fda.gov |
| June 27, 1997 | K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | Substantially Equivalent | Tosoh Medics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Hemoglobin A1c Test System
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Hemoglobin A2 Quantitation
- All makers of Fluorometer, For Clinical Use
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Updated October 3, 2025. 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.