510(k) K883327 ยท JGZ O-Phthalaldehyde, Urea Nitrogen
CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Jan 23, 1989 |
| Received | Aug 8, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883327
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.