510(k) K000331 ยท JIS Calibrator, Primary
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 10, 2000 |
| Received | Dec 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000331
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.