510(k) K102419 ยท JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
GSP NEONATAL IRT KIT (3306-001U)
| Applicant | Wallac Oy, Subsidiary of Perkinelmer, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 16, 2010 |
| Received | Aug 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102419
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.