510(k) K070810 ยท LGS Fluorescence Polarization Immunoassay, Theophylline
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
| Applicant | Biokit, S.A., Barcelona, ES |
| Decision | Substantially Equivalent, Jun 8, 2007 |
| Received | Mar 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070810
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.