510(k) K972331 ยท LGQ Fluorescence Polarization Immunoassay, Phenobarbital
INNOFLUOR GENTAMICIN ASSAY SYSTEM
| Applicant | Oxis Intl., Inc., Portland OR, US |
| Decision | Substantially Equivalent, Aug 1, 1997 |
| Received | Jun 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972331
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.