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 15, 2026, FDA's public records list OXIS International with 11 510(k) clearances. The most recent is a 510(k) clearance dated Aug 1, 1997: INNOFLUOR GENTAMICIN ASSAY SYSTEM.
| Aug 1, 1997 | INNOFLUOR GENTAMICIN ASSAY SYSTEMK972331 · LGQ | 510(k) clearances |
| Jul 14, 1997 | INNOFLUOR PHENOBARBITAL ASSAY SYSTEMK972330 · LGQ | 510(k) clearances |
| May 12, 1997 | INNOFLOUR CALIBRATOR REAGENT SETK970509 · DLJ | 510(k) clearances |
| May 12, 1997 | INNOFLOUR TOPIRAMATE REAGENT SETK970510 · MSL | 510(k) clearances |
| May 12, 1997 | INNOFLUOR TOPIRAMATE CONTROL SETK970517 · LAS | 510(k) clearances |
| Apr 4, 1996 | INNOFLUOR QUINIDINE ASSAY SYSTEMK955568 · LBZ | 510(k) clearances |
| Feb 9, 1996 | INNOFLUOR AMIKACIN ASSAY SYSTEMK955570 · KLQ | 510(k) clearances |
| Feb 9, 1996 | INNOFLUOR GENTAMICIN ASSAY SYSTEMK955569 · LCQ | 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
