Diagnostics makerLabelled 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 Bio Mega Diagnostic with 5 510(k) clearances. The most recent is a 510(k) clearance dated Feb 4, 1987: BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH.
| Feb 4, 1987 | BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSHK864659 · JLW | 510(k) clearances |
| Sep 21, 1982 | BIOMEGA MODEL 59WK822438 · DXN | 510(k) clearances |
| Jan 22, 1982 | MOD. 587 BLOOD PRESSURE & PULSE MONITORK813556 · DXN | 510(k) clearances |
| Aug 27, 1980 | BIOMEGA #423-B BLOOD PRESSURE & PULSE CKK801923 · DXN | 510(k) clearances |
| Nov 9, 1976 | BLOOD PRESSURE & PULSE CHECKERK760930 · DXN | 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
