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 Binax with 30 510(k) clearances. The most recent is a 510(k) clearance dated Apr 14, 2010: BINAXNOW PBP2A TEST, MODEL 890-000.
| Date | Record | Source |
|---|---|---|
| Apr 14, 2010 | BINAXNOW PBP2A TEST, MODEL 890-000K090301 · MYI | 510(k) clearances |
| Feb 24, 2010 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000K091766 · MYI | 510(k) clearances |
| Dec 16, 2009 | BINAXNOX STAPHYLOCOCCUS AUREUS TESTK090964 · JWX | 510(k) clearances |
| Sep 4, 2009 | CLEARVIEW ADVANCED STREP A , MODEL 737-430K091489 · GTY | 510(k) clearances |
| Sep 1, 2009 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010K083744 · MJZ | 510(k) clearances |
| Aug 12, 2009 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TESTK092223 · PSZ | 510(k) clearances |
| Oct 23, 2008 | BINAXNOW G6PD TESTK080003 · JBF | 510(k) clearances |
| Nov 9, 2006 | BINAXNOW INFLUENZA A & B TESTK062109 · PSZ | 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
