Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Drew Scientific with 9 510(k) clearances. The most recent is a 510(k) clearance dated Dec 11, 2007: D3 HEMATOLOGY ANALYZER, MODEL D3.
| Dec 11, 2007 | D3 HEMATOLOGY ANALYZER, MODEL D3K071562 · GKZ | 510(k) clearances |
| Jul 13, 2007 | TRILOGY ANALYZERK070704 · CGA | 510(k) clearances |
| Jun 19, 2006 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KITK060510 · JJX | 510(k) clearances |
| Dec 29, 2004 | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KITK043378 · JIT | 510(k) clearances |
| Sep 18, 2001 | DS30 HCY BLOOD COLLECTION TUBESK012152 · GIM | 510(k) clearances |
| Feb 11, 1999 | DS30 HCY HOMOCYSTEINE ASSAY KITK982003 · LPS | 510(k) clearances |
| Sep 9, 1993 | 745 GLYCOMATK933287 · LCP | 510(k) clearances |
| Nov 16, 1992 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITK924496 · JPD | 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
