510(k) K960182 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
| Applicant | Mardx Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 20, 1996 |
| Received | Jan 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960182
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.