Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
FDA 510(k) K151487 · Diatron U.S., Inc.
510(k) numberK151487
Submission
- Device name
- Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
- Applicant
- Diatron U.S., Inc.
Hialeah, FL, US - Received
- June 2, 2015
- Decision date
- January 14, 2016
- 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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|---|---|---|---|
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| 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 |
| 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 |
| 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 Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method cleared by the FDA?
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method (K151487) received a 510(k) decision of Substantially Equivalent on January 14, 2016, 226 days after the submission was received.
What is the product code of K151487?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.