510(k) K813375 ยท KSA Calibrator For Red-Cell And White-Cell Counting
HEMATOLOGY CALIBRATOR S-CAL
| Applicant | Coulter Electronics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 4, 1982 |
| Received | Dec 1, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813375
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.