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510(k) K190335

GSP Neonatal Total Galactose kit by Perkinelmer, Inc. — Product Code JIA

K190335 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "GSP Neonatal Total Galactose kit". The FDA issued a decision of Substantially Equivalent on November 6, 2019. The device falls under product code JIA (Enzymatic Methods, Galactose), a Class I device regulated under 21 CFR 862.1310. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2019
Date Received
February 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Methods, Galactose
Device Class
Class I
Regulation Number
862.1310
Review Panel
CH
Submission Type

Other clearances by Perkinelmer, Inc.

  • DEN200044 — Eonis SCID-SMA Kit (November 9, 2022)
  • K203035 — 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)
  • 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 JIA

  • K133652 — GSP NEONATAL TOTAL GALACTOSE KIT (April 28, 2014)
  • K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (June 20, 2013)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY (June 21, 1999)
  • K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (June 21, 1999)
  • K991498 — ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (June 16, 1999)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 1996)
  • K951329 — IMMUCHEM GAL-MW EA (November 9, 1995)

FDA data resources