Tosoh Corp.
Washington, D.C., DC, US
Tosoh Corp. appears in FDA device records in Washington, D.C., DC. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Tosoh Corp. between 1990 and 1992. The busiest year on record is 1990, with 5. The most recent is 1992, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 5 |
| 1991 | 3 |
| 1992 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | Substantially Equivalent | |
| K913663 | AIA-PACK T-U | KHQ | Substantially Equivalent | |
| K913298 | AIA-PACK CK-MB | JHX | Substantially Equivalent | |
| K913493 | AIA-PACK FT4 | CEC | Substantially Equivalent | |
| K903628 | AIA-PACK IRI | CFP | Substantially Equivalent | |
| K901965 | MPR-4A - MICRO-PLATE READER | JJQ | Substantially Equivalent | |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | Substantially Equivalent | |
| K897001 | TOSOH AIA-PACK T3 | CDP | Substantially Equivalent | |
| K896982 | AIA-PACK T4 | KLI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- KHOFluorometer, For Clinical Use
- JHXFluorometric Method, Cpk Or Isoenzymes
- KHQRadioassay, Triiodothyronine Uptake
- CECRadioimmunoassay, Free Thyroxine
- CFPRadioimmunoassay, Immunoreactive Insulin
- CDPRadioimmunoassay, Total Triiodothyronine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain