510(k) K901975 ยท LKH Antisera, Immunoperoxidase, Chlamydia Spp.
IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
| Applicant | Savyon Diagnostics , Ltd., Ashdod, IL |
| Decision | Substantially Equivalent, Mar 8, 1991 |
| Received | May 1, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901975
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.