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510(k) K071649

NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B by Wallac OY — Product Code JIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2008
Date Received
June 18, 2007
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

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  • K003664 — DELFIA NEONATAL IRT KIT, MODEL A005-110 (February 14, 2001)

Other clearances for product code JIA

  • K190335 — GSP Neonatal Total Galactose kit (November 6, 2019)
  • K133652 — GSP NEONATAL TOTAL GALACTOSE KIT (April 28, 2014)
  • K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (June 20, 2013)
  • 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)