510(k) K081251 ยท LSW Anti-Dna Antibody, Antigen And Control
MODIFICATION TO AESKULISA DS DNA G
| Applicant | Aesku Diagnostics, Wendelsheim, Rheinland, DE |
| Decision | Substantially Equivalent, May 13, 2008 |
| Received | May 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081251
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.