ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
FDA 510(k) K220977 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
510(k) numberK220977
Submission
- Device name
- ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
- Applicant
- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Suzhou, CN - Received
- April 4, 2022
- Decision date
- July 20, 2023
- 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
Other 510(k)s with product code JGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252475 | ABL90 FLEX PLUS SystemJGS · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| 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 |
| K180428 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 08/15/2018SE |
More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K221114 | Immunoglobulin G (IgG)CFN · Traditional | 08/02/2023SE |
Questions and answers
When was ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer cleared by the FDA?
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (K220977) received a 510(k) decision of Substantially Equivalent on July 20, 2023, 472 days after the submission was received.
What is the product code of K220977?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.