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510(k) K972004

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS by Alko Diagnostic Corp. — Product Code CGZ

K972004 is an FDA 510(k) premarket notification submitted by Alko Diagnostic Corp. for the device "ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS". The FDA issued a decision of Substantially Equivalent on June 16, 1997. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Alko Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
May 30, 1997
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 Alko Diagnostic Corp.

  • K001484 — CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; (June 19, 2000)
  • K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID R (September 1, 1998)
  • K970921 — STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (April 8, 1997)
  • K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (December 18, 1996)
  • K963734 — ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS (October 24, 1996)
  • K960085 — ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS (March 11, 1996)
  • K955154 — CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT (December 11, 1995)
  • K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (July 24, 1995)
  • K950902 — ALKO TONOMETERED SALINE CONTROL (March 30, 1995)
  • K944922 — ALKO CAL PACKS FOR CORNING 654 ANALYZERS (February 10, 1995)

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