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.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Hemagen Diagnostics with 52 510(k) clearances. The most recent is a 510(k) clearance dated Jun 30, 2004: RAICHEM GLUCOSE UV (LIQUID).
| Jun 30, 2004 | RAICHEM GLUCOSE UV (LIQUID)K041052 · CFR | 510(k) clearances |
| Jun 30, 2004 | RAICHEM BUN RATE REAGENT (LIQUID)K041051 · CDQ | 510(k) clearances |
| Jun 25, 2004 | RAICHEM CALCIUM (OCPC) LIQUID REAGENTK041009 · CIC | 510(k) clearances |
| Jun 16, 2003 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K031101 · JJY | 510(k) clearances |
| Dec 24, 2002 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK023784 · LBR | 510(k) clearances |
| Sep 17, 2002 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENTK022772 · MRR | 510(k) clearances |
| Sep 3, 2002 | RAICHEM LIPID CALIBRATORK022767 · JIX | 510(k) clearances |
| Jul 29, 2002 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEMK021194 · DCK | 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
