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., part of Thermo Fisher ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Remel with 164 510(k) clearances and 86 device recalls. The most recent is a device recall dated Jan 4, 2019: SWIN 2017 database, Model YSW4000.
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.
| Date | Record | Source |
|---|---|---|
| Jan 4, 2019 | SWIN 2017 database, Model YSW4000Class II · Potential for out of range microbial results | Device recalls |
| May 1, 2017 | Remel Spectra ESBLK162620 · JSO | 510(k) clearances |
| Jul 12, 2013 | REMEL XPECT FLU A&BK131804 · GNX | 510(k) clearances |
| Oct 8, 2010 | REMEL SPECTRA MRSAK092407 · JSO | 510(k) clearances |
| Nov 26, 2007 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSEK072827 · MJE | 510(k) clearances |
| Nov 15, 2004 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BK041951 · LLH | 510(k) clearances |
| Feb 26, 2004 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYK033479 · LLH | 510(k) clearances |
| Nov 18, 2003 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020K031942 · MHI | 510(k) clearances |
| Nov 14, 2003 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020K031965 · MHJ | 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
