Home / 510(k) Clearances / K190266

510(k) K190266

NeoLSD MSMS Kit by Perkinelmer, Inc. — Product Code PQW

K190266 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "NeoLSD MSMS Kit". The FDA issued a decision of Substantially Equivalent on May 3, 2019. The device falls under product code PQW (Alpha-D-Galactosidase A (Gla) Newborn Screening Test System), a Class II device regulated under 21 CFR 862.1488. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2019
Date Received
February 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Device Class
Class II
Regulation Number
862.1488
Review Panel
CH
Submission Type

For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.

Other clearances by Perkinelmer, Inc.

  • K203035 — Eonis SCID-SMA kit (November 9, 2022)
  • DEN200044 — Eonis SCID-SMA Kit (November 9, 2022)
  • K193103 — NeoBase 2 Non-derivatized MSMS Kit (February 7, 2020)
  • DEN180056 — GSP Neonatal Creatine Kinase - MM kit (December 12, 2019)
  • K190335 — GSP Neonatal Total Galactose kit (November 6, 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 PQW

  • K173829 — NeoLSD MSMS kit (July 18, 2018)
  • DEN150035 — SEEKER System (February 3, 2017)

FDA data resources