FirmLabelled 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 Bion Enterprises, Ltd. and its 1 subsidiaries with 14 510(k) clearances and 3 device recalls. The most recent is a device recall dated Jan 23, 2013: Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a u….
| Jan 23, 2013 | Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluoresceClass III · Affected products have a labeled expiration date of one year too long. | Device recalls |
| Jan 23, 2013 | Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent aClass III · Affected products have a labeled expiration date of one year too long. | Device recalls |
| Jan 23, 2013 | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent aClass III · Affected products have a labeled expiration date of one year too long. | Device recalls |
| Jun 15, 1993 | BION MUMPS-G ANTIBODY TEST SYSTEMK926066 · CAR | 510(k) clearances |
| Apr 5, 1990 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK901054 · LSR | 510(k) clearances |
| Oct 24, 1989 | VARICELLA ZOSTER VIRUSK894622 · GQW | 510(k) clearances |
| Oct 16, 1989 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGENK894626 · LLM | 510(k) clearances |
| Oct 16, 1989 | RESPIRATORY SYNCYTIAL VIRUSK894623 · LKT | 510(k) clearances |
| Oct 16, 1989 | MUMPS VIRUSK894624 · GRA | 510(k) clearances |
| Aug 31, 1989 | BION EBV-G (VCA) TEST SYSTEMK891785 · JRY | 510(k) clearances |
| Aug 15, 1989 | CHLAMYDIA (LGV-1)K894625 · LKI | 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
