Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent
FDA 510(k) K103788 · Horiba Abx SAS
510(k) numberK103788
Submission
- Device name
- Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent
- Applicant
- Horiba Abx SAS
Montpellier, FR - Received
- December 27, 2010
- Decision date
- November 8, 2011
- 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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|---|---|---|---|
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | Roche Diagnostics | 02/12/2026SE |
| K252357 | Glucose2CFR · Traditional | Abbott Ireland | 10/24/2025SE |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…CFR · Traditional | Roche Diagnostics | 09/16/2022SE |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsCFR · Traditional | Roche Diagnostics | 08/16/2019SE |
| K170316 | Alinity C Glucose Reagent Kit, Alinity C SystemCFR · Traditional | Abbott Laboratories | 10/19/2017SE |
| 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 |
| K131189 | Unicel DXC Synchron Systems Glucose Reagent (Gluh)CFR · Traditional | Beckman Coulter, Inc. | 04/17/2014SE |
| 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 |
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Questions and answers
When was Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent cleared by the FDA?
Pentra C200, Ise Module and Abx Pentra Glucose HK CP Reagent (K103788) received a 510(k) decision of Substantially Equivalent on November 8, 2011, 316 days after the submission was received.
What is the product code of K103788?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.