510(k) K895648 ยท JIT Calibrator, Secondary
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
| Applicant | Ventrex Laboratories, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Jan 18, 1990 |
| Received | Sep 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895648
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.