Chempro 1000
FDA 510(k) K854260 · Sen Tech Medical Corp.
510(k) numberK854260
Submission
- Device name
- Chempro 1000
- Applicant
- Sen Tech Medical Corp.
Arden Hills, MN, US - Received
- October 23, 1985
- Decision date
- November 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K210933 | YSI 2900C Biochemistry AnalyzerCGA · Traditional | Ysi, Inc. | 09/30/2024SE |
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| 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 |
|---|---|---|
| K910071 | Porta Gas Compressed Gas Cylinder CartGET · Traditional | 03/22/1991SE |
| K855091 | Chem-Pro 1000 Clinical Chemistry-Analysis SysCDS · Traditional | 03/14/1986SE |
| K851100 | Chem Pro 1000 Chemistry AnalysisCEM · Traditional | 07/09/1985SE |
| K841575 | Sentech's Ulab 1000 Clinical Chem.CEM · Traditional | 07/06/1984SE |
Questions and answers
When was Chempro 1000 cleared by the FDA?
Chempro 1000 (K854260) received a 510(k) decision of Substantially Equivalent on November 19, 1985, 27 days after the submission was received.
What is the product code of K854260?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.