510(k) K172348 ยท LSW Anti-Dna Antibody, Antigen And Control
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
| Applicant | Aesku.Diagnostics GmbH & Co. KG, Wendeslheim, DE |
| Decision | Substantially Equivalent, Feb 16, 2018 |
| Received | Aug 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172348
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.