510(k) K964787 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
| Applicant | Mardx Diagnostics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 8, 1997 |
| Received | Nov 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964787
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.