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510(k) K003668

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 by Wallac OY — Product Code CGZ

K003668 is an FDA 510(k) premarket notification submitted by Wallac OY for the device "AUTODELFIA NEONATAL IRT KIT, MODEL B005-112". The FDA issued a decision of Substantially Equivalent on February 12, 2001. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Wallac OY has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2001
Date Received
November 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

Other clearances by Wallac OY

  • DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (December 15, 2014)
  • K131284 — GSP NEONATAL BIOTINIDASE KIT (November 14, 2013)
  • 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)

Other clearances for product code CGZ

  • K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITR (October 30, 2018)
  • K170320 — Alinity c ICT Sample Diluent (October 24, 2017)
  • K162020 — VITROS Chemistry Products Cl- Slides (December 16, 2016)
  • K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR (August 21, 2008)
  • K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (April 14, 2008)
  • K070531 — ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALY (September 4, 2007)
  • K060108 — COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 (February 16, 2006)
  • K052027 — OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 (September 29, 2005)
  • K020148 — pHoenix ISE Reagents FOR Olympus AU Chemistry Systems (February 4, 2002)
  • K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES (December 18, 2001)

FDA data resources