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510(k) K131284

GSP NEONATAL BIOTINIDASE KIT by Wallac OY — Product Code NAK

K131284 is an FDA 510(k) premarket notification submitted by Wallac OY for the device "GSP NEONATAL BIOTINIDASE KIT". The FDA issued a decision of Substantially Equivalent on November 14, 2013. The device falls under product code NAK (System, Test, Biotinidase), a Class II device regulated under 21 CFR 862.1118. Wallac OY has at least 10 other 510(k) clearances on record.

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

Other clearances by Wallac OY

  • DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (December 15, 2014)
  • K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (July 23, 2010)
  • K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (April 16, 2009)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (April 14, 2008)
  • K050709 — RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, (March 8, 2006)
  • K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (July 11, 2005)
  • K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K003664 — DELFIA NEONATAL IRT KIT, MODEL A005-110 (February 14, 2001)

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)

FDA data resources