Unicel DXC Synchron Systems Glucose Reagent (Gluh)
FDA 510(k) K131189 · Beckman Coulter, Inc.
510(k) numberK131189
Submission
- Device name
- Unicel DXC Synchron Systems Glucose Reagent (Gluh)
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- April 26, 2013
- Decision date
- April 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…CFR · Traditional | Elitechgroup | 09/07/2016SE |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase…CFR · Traditional | Diatron U.S., Inc. | 01/14/2016SE |
| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 04/23/2013SE |
| K120681 | Advia Chemistry GLUH_3 ReagentsCFR · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/15/2012SE |
| K120369 | Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu)CFR · Traditional | Hitachi Chemical Diagnostics, Inc. | 05/10/2012SE |
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Questions and answers
When was Unicel DXC Synchron Systems Glucose Reagent (Gluh) cleared by the FDA?
Unicel DXC Synchron Systems Glucose Reagent (Gluh) (K131189) received a 510(k) decision of Substantially Equivalent on April 17, 2014, 356 days after the submission was received.
What is the product code of K131189?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.