510(k) K991890 ยท MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Aug 9, 1999 |
| Received | Jun 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991890
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.