510(k) K002107 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
| Applicant | Scimedx Corp., Denvill NJ, US |
| Decision | Substantially Equivalent, Aug 4, 2000 |
| Received | Jul 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002107
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.