510(k) K810215 ยท JHI Visual, Pregnancy Hcg, Prescription Use
DAC-CEL HCG
| Applicant | Burroughs Wellcome Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 17, 1981 |
| Received | Jan 27, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810215
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.