510(k) K852760 ยท JHI Visual, Pregnancy Hcg, Prescription Use
LBK 1244 DELFIA HCG KIT
| Applicant | Lkb Instruments, Inc., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Dec 5, 1985 |
| Received | Jun 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852760
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.