ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
FDA 510(k) K161837 · Beckman Coulter, Inc.
510(k) numberK161837
Submission
- Device name
- ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- July 5, 2016
- Decision date
- December 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
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| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 07/20/2023SE |
| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
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Questions and answers
When was ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer cleared by the FDA?
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (K161837) received a 510(k) decision of Substantially Equivalent on December 16, 2016, 164 days after the submission was received.
What is the product code of K161837?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.