510(k) K042644 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
AESKULISA TTG A AND AESKULISA TTG G
| Applicant | Aesku, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jun 1, 2005 |
| Received | Sep 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2019 | Bio-Rad Labs Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive entero Completed |
MVM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.