The following data is part of a premarket notification filed by Perkinelmer Inc. with the FDA for Neobase 2 Non-derivatized Msms Kit.
| Device ID | K193103 |
| 510k Number | K193103 |
| Device Name: | NeoBase 2 Non-derivatized MSMS Kit |
| Classification | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Applicant | PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 |
| Contact | Eva Nalian |
| Correspondent | Eva Nalian PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 |
| Product Code | NQL |
| CFR Regulation Number | 862.1055 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2020-02-07 |