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510(k) K131284

GSP NEONATAL BIOTINIDASE KIT by Wallac OY — Product Code NAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2013
Date Received
May 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Biotinidase
Device Class
Class II
Regulation Number
862.1118
Review Panel
CH
Submission Type

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Other clearances for product code NAK

  • K090123 — NEONATAL BIOTINIDASE KIT, MODEL 3018 (March 5, 2010)
  • K080294 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT (November 4, 2008)
  • K010844 — ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K (September 21, 2001)
  • DEN990008 — WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 (February 15, 2000)