Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry Systems
FDA 510(k) K963734 · Alko Diagnostic Corp.
510(k) numberK963734
Submission
- Device name
- Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry Systems
- Applicant
- Alko Diagnostic Corp.
Holliston, MA, US - Received
- August 29, 1996
- Decision date
- October 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…CGZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/30/2018SE |
| K170320 | Alinity c ICT Sample DiluentCGZ · Traditional | Abbott Laboratories | 10/24/2017SE |
| K162020 | VITROS Chemistry Products Cl- SlidesCGZ · Traditional | Ortho Clinical Diagnostics | 12/16/2016SE |
| K082099 | Vitros Chemistry Products Ci-Dt Slides; Vitros Chemistry Products DT Calibrator Kit…CGZ · Special | Ortho-Clinical Diagnostics, Inc. | 08/21/2008SE |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112CGZ · Traditional | Wallac OY | 04/14/2008SE |
| K070531 | Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry AnalyzerCGZ · Traditional | Thermo Fisher Scientific | 09/04/2007SE |
| K060108 | Cobas Integra Chloride Elctrode GEN.2CGZ · Special | Roche Diagnostics Corp. | 02/16/2006SE |
| K052027 | Opti Lion Electrolyte Analyzer, Model GD7200CGZ · Traditional | Osmetech, Inc. | 09/29/2005SE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsCGZ · Traditional | Phoenix Diagnostics, Inc. | 02/04/2002SE |
| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 SeriesCGZ · Traditional | Phoenix Diagnostics, Inc. | 12/18/2001SE |
More from Phoenix Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001484 | Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse…JIX · Traditional | 06/19/2000SE |
| K982501 | Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent…JIX · Traditional | 09/01/1998SE |
| K972004 | Ise Reagents for Olympus Au 800/AU5200 Chemistry SystemsCGZ · Traditional | 06/16/1997SE |
| K970921 | Standard a Multiply (A540-0), Standard B Multiply (A550-0), Standard C Multiply (A560-0)JIX · Traditional | 04/08/1997SE |
| K962864 | THB Cal Standard for Il Co-Oximeters/OximetersKRZ · Traditional | 12/18/1996SE |
| K960085 | Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak SystemsJIX · Traditional | 03/11/1996SE |
| K955154 | Cal 1 & Cal 2 Solution, Flush Solution KitJIX · Traditional | 12/11/1995SE |
| K951071 | Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional | 07/24/1995SE |
| K950902 | Alko Tonometered Saline ControlJJS · Traditional | 03/30/1995SE |
| K945966 | Alko Calibrators and Flush Solution for Il 1300 Series Ph/Blood Gas AnalyzersJIX · Traditional | 02/10/1995SE |
Questions and answers
When was Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry Systems cleared by the FDA?
Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry Systems (K963734) received a 510(k) decision of Substantially Equivalent on October 24, 1996, 56 days after the submission was received.
What is the product code of K963734?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.