510(k) K943268 ยท KSA Calibrator For Red-Cell And White-Cell Counting
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
| Applicant | Streck Laboratories, Inc., Omaha NE, US |
| Decision | Substantially Equivalent, Dec 15, 1994 |
| Received | Jul 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943268
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.