510(k) K061549 ยท JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio
AMNIOSTAT-FLM-PG
| Applicant | Irvine Scientific Sales Co., Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Oct 18, 2006 |
| Received | Jun 5, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061549
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.