510(k) K974322 ยท DOP Mass Spectrometer, Clinical Use
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
| Applicant | Europa Scientific, Ltd., Concord MA, US |
| Decision | Substantially Equivalent, Dec 16, 1997 |
| Received | Nov 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974322
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.