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 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Seradyn with 30 510(k) clearances. The most recent is a 510(k) clearance dated May 17, 2007: SERADYN QMS TOPIRAMATE.
| Date | Record | Source |
|---|---|---|
| May 17, 2007 | SERADYN QMS TOPIRAMATEK070645 · NWM | 510(k) clearances |
| Jan 12, 2007 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSK062966 · ORH | 510(k) clearances |
| Sep 22, 2006 | ARCHITECT CORTISOL ASSAYK062204 · JFT | 510(k) clearances |
| Jul 21, 2006 | QMS TOBRAMYCINK060998 · LCR | 510(k) clearances |
| Jun 15, 2006 | MULTIGENT GENTAMICINK060709 · LCD | 510(k) clearances |
| Dec 23, 2005 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORSK052826 · LBZ | 510(k) clearances |
| Nov 18, 2005 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLSK051211 · NWM | 510(k) clearances |
| Nov 1, 2005 | QMS AMIKACIN REAGENTSK052815 · KLQ | 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
