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 Monobind with 23 510(k) clearances. The most recent is a 510(k) clearance dated Jul 20, 2018: Free Testosterone AccuBind ELISA Test System.
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 |
|---|---|---|
| Jul 20, 2018 | Free Testosterone AccuBind ELISA Test SystemK181017 · CDZ | 510(k) clearances |
| Apr 4, 2008 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300K063437 · JLW | 510(k) clearances |
| Aug 22, 2003 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300K030860 · KLI | 510(k) clearances |
| Apr 5, 2002 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300K020548 · CEC | 510(k) clearances |
| Feb 4, 1998 | T-UPTAKE MICROPLATE EIAK980088 · KHQ | 510(k) clearances |
| Sep 2, 1997 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)K972720 · CGJ | 510(k) clearances |
| Jul 3, 1997 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAK971835 · DDC | 510(k) clearances |
| Jul 3, 1997 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAK971834 · JNL | 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
