510(k) K133652 ยท JIA Enzymatic Methods, Galactose
GSP NEONATAL TOTAL GALACTOSE KIT
| Applicant | Wallac Oy, A Subsidiary of Perkinelmer, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 28, 2014 |
| Received | Nov 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133652
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.