510(k) K121101 ยท JIA Enzymatic Methods, Galactose
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
| Applicant | Astoria-Pacific, Inc., Clackamas OR, US |
| Decision | Substantially Equivalent, Jun 20, 2013 |
| Received | Apr 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121101
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.