Company ยท US
Tosoh Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2002. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KHO | Fluorometer, For Clinical Use | 2 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2002 | K023240 | ST AIA-PACK CA 19-9 Tosoh Corp. | NIG |
| Dec 23, 2002 | K023239 | AIA-PACK CA 19-9 Tosoh Corp. | NIG |
| Jul 21, 1992 | K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Corp. | KHO |
| Sep 30, 1991 | K913663 | AIA-PACK T-U Tosoh Corp. | KHQ |
| Sep 27, 1991 | K913298 | AIA-PACK CK-MB Tosoh Corp. | JHX |
| Sep 10, 1991 | K913493 | AIA-PACK FT4 Tosoh Corp. | CEC |
| Sep 7, 1990 | K903628 | AIA-PACK IRI Tosoh Corp. | CFP |
| May 10, 1990 | K901965 | MPR-4A - MICRO-PLATE READER Tosoh Corp. | JJQ |
| May 2, 1990 | K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM Tosoh Corp. | KHO |
| Mar 9, 1990 | K897001 | TOSOH AIA-PACK T3 Tosoh Corp. | CDP |
| Mar 9, 1990 | K896982 | AIA-PACK T4 Tosoh Corp. | KLI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||