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510(k) K052027

OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 by Osmetech, Inc. — Product Code CGZ

K052027 is an FDA 510(k) premarket notification submitted by Osmetech, Inc. for the device "OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200". The FDA issued a decision of Substantially Equivalent on September 29, 2005. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Osmetech, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2005
Date Received
July 27, 2005
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 Osmetech, Inc.

  • K061730 — OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 (August 4, 2006)
  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)
  • K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (November 30, 2001)

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

FDA data resources