510(k) K193103 ยท NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
NeoBase 2 Non-derivatized MSMS Kit
| Applicant | Perkinelmer, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Feb 7, 2020 |
| Received | Nov 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193103
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.