Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FinlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Orion CorporationLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orion Diagnostica with 36 510(k) clearances. The most recent is a 510(k) clearance dated Mar 10, 2016: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and Quik….
| Mar 10, 2016 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go InstrumentK142993 · DCK | 510(k) clearances |
| May 4, 2005 | ORION DIAGNOSTICA UNIQ PINP RIAK043125 · CIN | 510(k) clearances |
| Nov 18, 2004 | QUIKREAD CRP CALIBRATOR SETK042625 · JJY | 510(k) clearances |
| Sep 24, 2004 | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODEK042442 · DCK | 510(k) clearances |
| Oct 10, 2003 | ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROLK031607 · DCK | 510(k) clearances |
| Dec 3, 2002 | ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257K022176 · DCK | 510(k) clearances |
| Jun 27, 1997 | PYLORISET EIA-G (68926)K971537 · LYR | 510(k) clearances |
| Apr 5, 1995 | PYLORISET DRYK942974 · LYR | 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
