510(k) K970933 ยท JIS Calibrator, Primary
AUTO HDL CHOLESTEROL CALIBRATOR
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, May 23, 1997 |
| Received | Mar 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970933
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.