510(k) K011348 ยท MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
PHASE II GBM IGG ANTIBODY EIA TEST
| Applicant | Scimedx Corp., Denvill NJ, US |
| Decision | Substantially Equivalent, Jun 25, 2001 |
| Received | May 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011348
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.