Stat Profile Prime Plus Analyzer System
FDA 510(k) K200349 · Nova Biomedical Corporation
510(k) numberK200349
Submission
- Device name
- Stat Profile Prime Plus Analyzer System
- Applicant
- Nova Biomedical Corporation
Walham, MA, US - Received
- February 12, 2020
- Decision date
- March 13, 2020
- 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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| K232075 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | 02/23/2024SE |
| 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 |
| K193246 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | 01/24/2020SE |
Questions and answers
When was Stat Profile Prime Plus Analyzer System cleared by the FDA?
Stat Profile Prime Plus Analyzer System (K200349) received a 510(k) decision of Substantially Equivalent on March 13, 2020, 30 days after the submission was received.
What is the product code of K200349?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.