510(k) K981354 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, May 1, 1998 |
| Received | Apr 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981354
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2005 | Beckman Coulter Inc Access Immunoassay Systems Assay Protocol: Dil-AFP. Terminated |
LOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.