510(k) K862043 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
DELFIA (TM) HFSH KIT
| Applicant | Lkb Instruments, Inc., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Jun 24, 1986 |
| Received | May 28, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2016 | PerkinElmer Health Sciences, Inc. DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum Terminated |
CGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.