510(k) K834616 ยท JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio
AMNIO STAT-FLM AGGLUTINATION TEST
| Applicant | Hana Biologics, Inc., Walker MI, US |
| Decision | Substantially Equivalent, May 25, 1984 |
| Received | Dec 14, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834616
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.