Nova Primary Glucose Analyzer System
FDA 510(k) K203549 · Nova Biomedical Corporation
510(k) numberK203549
Submission
- Device name
- Nova Primary Glucose Analyzer System
- Applicant
- Nova Biomedical Corporation
Waltham, ME, US - Received
- December 4, 2020
- Decision date
- October 18, 2022
- 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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| 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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| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
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| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | 11/22/2024SE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | 11/19/2024SE |
| K232075 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | 02/23/2024SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 09/29/2023SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | 04/14/2020SE |
| K200204 | Stat Profile Prime Plus Analyzer SystemGGZ · Traditional | 04/06/2020SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | 03/13/2020SE |
| K193246 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 01/24/2020SE |
Questions and answers
When was Nova Primary Glucose Analyzer System cleared by the FDA?
Nova Primary Glucose Analyzer System (K203549) received a 510(k) decision of Substantially Equivalent on October 18, 2022, 683 days after the submission was received.
What is the product code of K203549?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.