510(k) K926066 ยท CAR Monitor, Spinal-Fluid Pressure, Electrically Powered
BION MUMPS-G ANTIBODY TEST SYSTEM
| Applicant | Bion Ent., Ltd., Park Ridge IL, US |
| Decision | Substantially Equivalent, Jun 15, 1993 |
| Received | Dec 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K926066
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2013 | Bion Enterprises Ltd Plastic bottle containing 3.5 mL of IgG FITC Conjugate
Product Usage:
Product is a used as a counterstain for various indirect fluorescent assay kits Terminated |
LJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.