Medical device makerLabelled 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 Di-Chem with 6 510(k) clearances. The most recent is a 510(k) clearance dated Aug 12, 2022: Hemo-Lyte C Cartridge.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 12, 2022 | Hemo-Lyte C CartridgeK202508 · KPO | 510(k) clearances |
| Oct 13, 2017 | CitryteK171015 · KPO | 510(k) clearances |
| Jan 18, 2002 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDERK012328 · KPO | 510(k) clearances |
| Jan 18, 2002 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONK012547 · KPO | 510(k) clearances |
| Apr 9, 1991 | FORMASURE TEST REAGENTK905217 · LIF | 510(k) clearances |
| Nov 17, 1982 | DIALYSATE ADDITIVES-POWDER/LIQUIDK823103 · KPO | 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
