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510(k) K203035

Eonis SCID-SMA kit by Perkinelmer, Inc. — Product Code PJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2022
Date Received
October 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Device Class
Class II
Regulation Number
866.5930
Review Panel
IM
Submission Type

A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).

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  • K190335 — GSP Neonatal Total Galactose kit (November 6, 2019)
  • K190266 — NeoLSD MSMS Kit (May 3, 2019)
  • K161966 — PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector (September 8, 2016)
  • K161942 — PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector (September 1, 2016)
  • K142698 — PerkinElmer, XRpad 4343 F MED Flat Panel Detector (October 23, 2014)
  • K140551 — PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR (August 1, 2014)
  • K121864 — PERKINELMER 226 SAMPLE COLLECTION DEVICES (March 12, 2013)

Other clearances for product code PJI

  • DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (December 15, 2014)