Medical device 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 Biochem International with 28 510(k) clearances. The most recent is a 510(k) clearance dated Apr 11, 1994: BIOCHEM MODEL 3302 NEWOX2 OXIMETER.
| Apr 11, 1994 | BIOCHEM MODEL 3302 NEWOX2 OXIMETERK920083 · DQA | 510(k) clearances |
| Dec 3, 1993 | 8100 ANESTHETIC AGENT MONITORK932389 · CBS | 510(k) clearances |
| May 26, 1993 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULEK921388 · DSK | 510(k) clearances |
| Jan 7, 1993 | BIOCHEM MODEL 3301 NEWOX1 OXIMETERK920082 · DQA | 510(k) clearances |
| Aug 22, 1991 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBPK911351 · DXN | 510(k) clearances |
| Aug 22, 1991 | BIOCHEM TEMPERATURE/ FIO2 MODULEK910381 · CCL | 510(k) clearances |
| Sep 4, 1990 | BIOCHEM 6100 NON-INVASIVE MONITORK903222 · DXN | 510(k) clearances |
| Jul 27, 1990 | BIOCHEM 9100 MULTIGAS MONITORK901861 · CCK | 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
