510(k) K970100 ยท MJX Kit, Serological, Positive Control
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
| Applicant | Simplicity Diagnostics, Inc., Hatboro PA, US |
| Decision | Substantially Equivalent, Mar 10, 1997 |
| Received | Jan 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970100
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.