510(k) K110274 ยท JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
AUTODELFIA NEONATAL IRT KIT
| Applicant | Wallac Oy, A Subsidiary of Perkinelmer, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 10, 2011 |
| Received | Jan 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)1904 Terminated |
JNO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.