Nova Glucose Low/High Level Control Solutions
FDA 510(k) K041016 · Nova Biomedical Corp.
510(k) numberK041016
Submission
- Device name
- Nova Glucose Low/High Level Control Solutions
- Applicant
- Nova Biomedical Corp.
Walham, MA, US - Received
- April 20, 2004
- Decision date
- May 7, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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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 |
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Questions and answers
When was Nova Glucose Low/High Level Control Solutions cleared by the FDA?
Nova Glucose Low/High Level Control Solutions (K041016) received a 510(k) decision of Substantially Equivalent on May 7, 2004, 17 days after the submission was received.
What is the product code of K041016?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.