510(k) K930685 ยท GKL Counter, Cell, Automated (Particle Counter)
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
| Applicant | Heraeus Kulzer, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 22, 1993 |
| Received | Feb 10, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930685
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.