510(k) K173568 ยท NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
NeoBase 2 Non-derivatized MSMS Kit
| Applicant | Wallac Oy, Subsidiary of Perkinelmer, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Sep 4, 2018 |
| Received | Nov 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173568
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.