510(k) K811588 ยท JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio
HELENA FETAL-TEK 200 METHOD
| Applicant | Helena Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 25, 1981 |
| Received | Jun 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811588
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.