StatStrip Glucose Hospital Meter System
FDA 510(k) K232075 · Nova Biomedical Corporation
510(k) numberK232075
Submission
- Device name
- StatStrip Glucose Hospital Meter System
- Applicant
- Nova Biomedical Corporation
Walham, MA, US - Received
- July 12, 2023
- Decision date
- February 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PZI – Prescription Use Blood Glucose Meter For Near-Patient Testing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
Other 510(k)s with product code PZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | Roche Diagnostics | 06/12/2026SE |
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemPZI · Dual Track | Taidoc Technology Corporation | 11/19/2024SE |
| K220272 | cobas pulse blood glucose monitoring systemPZI · Dual Track | Roche Diagnostics | 04/26/2024SE |
| K200788 | Assure Titanium Blood Glucose Monitoring SystemPZI · Dual Track | Arkray, Inc. | 05/23/2022SE |
| K182552 | StatStrip Xpress Glucose Hospital Meter SystemPZI · Dual Track | Nova Biomedical Corporation | 12/13/2018SE |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter SystemPZI · Dual Track | Nova Biomedical Corporation | 12/13/2018SE |
| K181043 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | Nova Biomedical Corporation | 07/12/2018SE |
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter SystemPZI · Special | Nova Biomedical Corporation | 01/06/2017SE |
| K161856 | StatStrip Xpress Glucose Hospital Meter SystemPZI · Special | Nova Biomedical Corporation | 11/15/2016SE |
| K152986 | StatStrip Xpress 2 Glucose Hospital Meter SystemPZI · Special | Nova Biomedical Corporation | 01/27/2016SE |
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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 StatStrip Glucose Hospital Meter System cleared by the FDA?
StatStrip Glucose Hospital Meter System (K232075) received a 510(k) decision of Substantially Equivalent on February 23, 2024, 226 days after the submission was received.
What is the product code of K232075?
The FDA product code is PZI – Prescription Use Blood Glucose Meter For Near-Patient Testing, a Class II (moderate risk) device regulated under 21 CFR 862.1345.