Careside Glucose
FDA 510(k) K981183 · Exigent Diagnostics, Inc.
510(k) numberK981183
Submission
- Device name
- Careside Glucose
- Applicant
- Exigent Diagnostics, Inc.
Culver City, CA, US - Received
- April 1, 1998
- Decision date
- May 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K252488 | ABL90 FLEX PLUS SystemCGA · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K210933 | YSI 2900C Biochemistry AnalyzerCGA · Traditional | Ysi, Inc. | 09/30/2024SE |
| K220328 | EasyStat 300CGA · Traditional | Medica Corporation | 07/26/2024SE |
| K223179 | Cholestech LDX SystemCGA · Dual Track | Alere San Diego, Inc. | 09/20/2023SE |
| K223755 | i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 09/11/2023SE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 07/28/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 08/13/2021SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K982118 | Careside AnalyzerCHH · Traditional | 07/24/1998SE |
| K981899 | Careside Hdl-CholesterolLBS · Traditional | 07/14/1998SE |
| K980043 | Careside CreatinineJFY · Traditional | 03/30/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | 03/06/1998SE |
| K980057 | Careside BunCDQ · Traditional | 02/05/1998SE |
| K980042 | Careside Total ProteinCEK · Traditional | 02/04/1998SE |
| K980041 | Careside AlbuminCIX · Traditional | 02/04/1998SE |
| K980055 | Careside GlobulinJGE · Traditional | 01/28/1998SE |
Questions and answers
When was Careside Glucose cleared by the FDA?
Careside Glucose (K981183) received a 510(k) decision of Substantially Equivalent on May 7, 1998, 36 days after the submission was received.
What is the product code of K981183?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.