Glucose Reagent for Glucose Analyzer
FDA 510(k) K780093 · Harleco
510(k) numberK780093
Submission
- Device name
- Glucose Reagent for Glucose Analyzer
- Applicant
- Harleco
Mchenry, IL, US - Received
- January 18, 1978
- Decision date
- February 13, 1978
- 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 |
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| 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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| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
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Questions and answers
When was Glucose Reagent for Glucose Analyzer cleared by the FDA?
Glucose Reagent for Glucose Analyzer (K780093) received a 510(k) decision of Substantially Equivalent on February 13, 1978, 26 days after the submission was received.
What is the product code of K780093?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.