510(k) K013548 ยท KPT Calibrator, Dose, Radionuclide
STANDARD IMAGING IVB 1000 WELL CHAMBER
| Applicant | Standard Imaging, Inc., Middleton WI, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Oct 24, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013548
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.