The following data is part of a premarket notification filed by Perkinelmer Inc. with the FDA for Neolsd Msms Kit.
| Device ID | K190266 |
| 510k Number | K190266 |
| Device Name: | NeoLSD MSMS Kit |
| Classification | Alpha-d-galactosidase A (gla) Newborn Screening Test System |
| Applicant | PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 |
| Contact | Brian Ciccariello |
| Correspondent | Brian Ciccariello PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 |
| Product Code | PQW |
| Subsequent Product Code | PQT |
| Subsequent Product Code | PQU |
| Subsequent Product Code | PQV |
| Subsequent Product Code | QCL |
| Subsequent Product Code | QCM |
| CFR Regulation Number | 862.1488 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-05-03 |