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 14, 2026, FDA's public records list Bionostics with 49 510(k) clearances. The most recent is a 510(k) clearance dated May 31, 2013: GLUCOSE METER-CHECK SOLUTION FOR TAIDOC.
| May 31, 2013 | GLUCOSE METER-CHECK SOLUTION FOR TAIDOCK131136 · JJX | 510(k) clearances |
| Feb 14, 2013 | GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEKK123851 · JJX | 510(k) clearances |
| Jan 25, 2013 | GLUCOSE METER-CHECK SOLUTION FOR BAYERK123966 · JJX | 510(k) clearances |
| Jan 30, 2012 | GLUCOSE METER-CHECK SOLUTION FOR INFOPIAK113764 · JJX | 510(k) clearances |
| Dec 23, 2011 | GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULTK112352 · JJX | 510(k) clearances |
| Sep 19, 2011 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSEK112356 · JJX | 510(k) clearances |
| Feb 10, 2011 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTIONK103553 · JJX | 510(k) clearances |
| Oct 1, 2010 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800K101831 · OSL | 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
