510(k) K970198 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
| Applicant | Scimedx Corp., Denvill NJ, US |
| Decision | Substantially Equivalent, Feb 20, 1997 |
| Received | Jan 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970198
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.