510(k) K883411 ยท JHF Colorimetric Method, Lecithin/Sphingomyelin Ratio
PG-NUMERIC(TM)
| Applicant | Isolab, Inc., Akron OH, US |
| Decision | Substantially Equivalent, Mar 15, 1989 |
| Received | Aug 15, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883411
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.