Alinity c ICT Sample Diluent
FDA 510(k) K170320 · Abbott Laboratories
510(k) numberK170320
Submission
- Device name
- Alinity c ICT Sample Diluent
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- February 1, 2017
- Decision date
- October 24, 2017
- 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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| 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 |
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| 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 |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | Wallac OY | 02/14/2001SE |
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Questions and answers
When was Alinity c ICT Sample Diluent cleared by the FDA?
Alinity c ICT Sample Diluent (K170320) received a 510(k) decision of Substantially Equivalent on October 24, 2017, 265 days after the submission was received.
What is the product code of K170320?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.