Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Tosoh CorporationLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Tosoh Medics with 41 510(k) clearances. The most recent is a 510(k) clearance dated Dec 18, 2002: ST AIA-PACK CEA ENZYME IMMUNOASSAY.
| Dec 18, 2002 | ST AIA-PACK CEA ENZYME IMMUNOASSAYK023893 · DHX | 510(k) clearances |
| Dec 17, 2002 | ST AIA-PACK AFP ENZYME IMMUNOASSAYK023894 · LOJ | 510(k) clearances |
| Dec 17, 2002 | ST AIA-PACK TESTOSTERONE ASSAYK023091 · CDZ | 510(k) clearances |
| Dec 6, 2002 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAYK023891 · LTK | 510(k) clearances |
| May 14, 2002 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEK020489 · JPD | 510(k) clearances |
| Dec 14, 2001 | AIA-PACK CTNI 2ND-GEN ASSAYK012820 · MMI | 510(k) clearances |
| Sep 18, 2001 | G7 AUTOMATED HPLC ANALYZERK011434 · LCP | 510(k) clearances |
| Aug 16, 2001 | AIA-PACK BRCA, ST AIA PACK BRCAK010796 · MOI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
