Astra Reagent Concentrate System
FDA 510(k) K812866 · Nobel Scientific Industries, Inc.
510(k) numberK812866
Submission
- Device name
- Astra Reagent Concentrate System
- Applicant
- Nobel Scientific Industries, Inc.
Mchenry, IL, US - Received
- October 13, 1981
- Decision date
- December 17, 1981
- 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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| 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 |
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| K854717 | Nsi Astra TM Total Protein Reagent Kit, Nsi #7928CEK · Traditional | 01/14/1986SE |
| K854716 | Nsi Astra TM Calcium Reagent Kit Nsi Item # 7909CIC · Traditional | 01/07/1986SE |
| K854718 | Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926CIX · Traditional | 12/19/1985SE |
| K850944 | Nsi Lysing-D Reagent -4000 MLGGK · Traditional | 03/29/1985SE |
| K844782 | Nsi Elt-D Diluting Fluid 4000MLGIF · Traditional | 03/05/1985SE |
| K823283 | Flushing Solution · Traditional | 12/03/1982SE |
| K810550 | Silver AnodeJFS · Traditional | 04/08/1981SE |
| K810549 | Thermal Printer PaperJJE · Traditional | 04/08/1981SE |
| K802518 | Bun Reagent Astra 4 & 8 AnalyzersCDN · Traditional | 11/12/1980SE |
| K801346 | Nsi Reagent System for Ortho ELT-8 HemaGIF · Traditional | 08/12/1980SE |
Questions and answers
When was Astra Reagent Concentrate System cleared by the FDA?
Astra Reagent Concentrate System (K812866) received a 510(k) decision of Substantially Equivalent on December 17, 1981, 65 days after the submission was received.
What is the product code of K812866?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.