The following data is part of a premarket notification filed by Perkinelmer Inc with the FDA for Eonis Scid-sma Kit.
Device ID | K203035 |
510k Number | K203035 |
Device Name: | Eonis SCID-SMA Kit |
Classification | Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System |
Applicant | PerkinElmer Inc 940 Winter St Waltham, MA 02451 |
Contact | Eva Nalian |
Correspondent | Casey Fox PerkinElmer Inc 940 Winter St Waltham, MA 02451 |
Product Code | PJI |
CFR Regulation Number | 866.5930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-05 |
Decision Date | 2022-11-09 |