Nova 10 Sodium/Potassium/Total Calciu
FDA 510(k) K833153 · Nova Biomedical Corp.
510(k) numberK833153
Submission
- Device name
- Nova 10 Sodium/Potassium/Total Calciu
- Applicant
- Nova Biomedical Corp.
Mchenry, IL, US - Received
- September 15, 1983
- Decision date
- November 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| K013654 | Precision Systems Analette Chemistry AnalyzerJJF · Traditional | Precision Systems, Inc. | 06/05/2002SE |
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| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
| K973177 | Mago Automated Eia ProcessorJJF · Traditional | Diamedix Corp. | 10/09/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | Synermed, Inc. | 06/26/1997SE |
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| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | 11/19/2024SE |
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| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 09/29/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | 10/18/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | 04/14/2020SE |
| K200204 | Stat Profile Prime Plus Analyzer SystemGGZ · Traditional | 04/06/2020SE |
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Questions and answers
When was Nova 10 Sodium/Potassium/Total Calciu cleared by the FDA?
Nova 10 Sodium/Potassium/Total Calciu (K833153) received a 510(k) decision of Substantially Equivalent on November 25, 1983, 71 days after the submission was received.
What is the product code of K833153?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.