510(k) K880679 ยท GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
BION CMV-G TEST SYSTEM
| Applicant | Bion Ent., Ltd., Park Ridge IL, US |
| Decision | Substantially Equivalent, Jun 3, 1988 |
| Received | Feb 19, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2013 | Bion Enterprises Ltd Plastic bottle containing 10.5 mL of IgM Conjugate
Product Usage:
Product is a used as a counterstain for various indirect fluorescent assay kits Terminated |
GQH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.