510(k) K923105 ยท JFJ Catalytic Methods, Amylase
MILES URINE AMYLASE METHOD
| Applicant | Heraeus Kulzer, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 28, 1992 |
| Received | Jun 19, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923105
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.