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510(k) K133652

GSP NEONATAL TOTAL GALACTOSE KIT by Wallac Oy, A Subsidiary of Perkinelmer, Inc. — Product Code JIA

K133652 is an FDA 510(k) premarket notification submitted by Wallac Oy, A Subsidiary of Perkinelmer, Inc. for the device "GSP NEONATAL TOTAL GALACTOSE KIT". The FDA issued a decision of Substantially Equivalent on April 28, 2014. The device falls under product code JIA (Enzymatic Methods, Galactose), a Class I device regulated under 21 CFR 862.1310. Wallac Oy, A Subsidiary of Perkinelmer, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2014
Date Received
November 27, 2013
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 Wallac Oy, A Subsidiary of Perkinelmer, Inc.

  • K173829 — NeoLSD MSMS kit (July 18, 2018)
  • K110274 — AUTODELFIA NEONATAL IRT KIT (June 10, 2011)
  • K103484 — GSP NEONATAL THYROXINE (T4) (April 22, 2011)

Other clearances for product code JIA

  • K190335 — GSP Neonatal Total Galactose kit (November 6, 2019)
  • 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)
  • K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (June 21, 1999)
  • K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY (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