510(k) K925255 ยท GKZ Counter, Differential Cell
TRAX(TM) CD4 TEST KIT
| Applicant | T Cell Diagnostics, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, May 15, 1995 |
| Received | Oct 19, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925255
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.