510(k) K970353 ยท MMW System, Test, Tumor Marker, Monitoring, Bladder
AURA TEK FDP
| Applicant | Perimmune, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Apr 30, 1997 |
| Received | Jan 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970353
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.