510(k) K864664 ยท KSA Calibrator For Red-Cell And White-Cell Counting
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
| Applicant | Technicon Instruments Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Feb 6, 1987 |
| Received | Nov 28, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864664
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.