510(k) K940817 ยท JHF Colorimetric Method, Lecithin/Sphingomyelin Ratio
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Feb 8, 1995 |
| Received | Feb 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940817
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.