The following data is part of a premarket notification filed by Wallac Oy, Subsidiary Of Perkinelmer, Inc. with the FDA for Neobase 2 Non-derivatized Msms Kit.
| Device ID | K173568 |
| 510k Number | K173568 |
| Device Name: | NeoBase 2 Non-derivatized MSMS Kit |
| Classification | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry |
| Applicant | Wallac Oy, Subsidiary Of PerkinElmer, Inc. 940 Winter Street Waltham, MA 02451 |
| Contact | Brian Carney |
| Correspondent | Anne Marie Whalen Wallac Oy, Subsidiary Of 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 | 2017-11-20 |
| Decision Date | 2018-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147356829 | K173568 | 000 |
| 06438147356812 | K173568 | 000 |
| 06438147348107 | K173568 | 000 |