The following data is part of a premarket notification filed by Wallac Oy, A Subsidiary Of Perkinelmer with the FDA for Neolsd Msms Kit.
| Device ID | K173829 |
| 510k Number | K173829 |
| Device Name: | NeoLSD MSMS Kit |
| Classification | Alpha-d-galactosidase A (gla) Newborn Screening Test System |
| Applicant | Wallac Oy, A Subsidiary Of PerkinElmer 940 Winter Street Waltham, MA 02451 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor Wallac Oy, A Subsidiary Of PerkinElmer 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 | 2017-12-18 |
| Decision Date | 2018-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147356218 | K173829 | 000 |