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 TOA Medical ElectronicsLabelled 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 TOA Medical Electronics USA with 33 510(k) clearances. The most recent is a 510(k) clearance dated May 2, 1994: SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER.
| May 2, 1994 | SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERK936023 · GKZ | 510(k) clearances |
| Jan 27, 1994 | TOA MEDICAL ELECTRONICS CA-5000K933886 · JPA | 510(k) clearances |
| Nov 3, 1993 | CA-1000 AUTOMATED COAGULATION ANALYZERK931149 · JPA | 510(k) clearances |
| Apr 29, 1992 | SYSMEX HEMATOLOGY SYSTEM ACCESSORIESK920544 · GKZ | 510(k) clearances |
| Dec 30, 1991 | SYSMEX NE-1500, MODIFICATIONK914744 · GKZ | 510(k) clearances |
| Sep 10, 1991 | SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZERK912494 · GKL | 510(k) clearances |
| Jul 26, 1991 | SYSMEX F-810K910849 · GKL | 510(k) clearances |
| Jul 26, 1991 | SYSMEX F-310K911173 · GKL | 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
