FDA Product Code
FDA Product Code PZI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | 2026-06-12 | Dual Track | PDF ↗ |
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | 2024-11-19 | Dual Track | PDF ↗ |
| K220272 | cobas pulse blood glucose monitoring system | Roche Diagnostics | 2024-04-26 | Dual Track | PDF ↗ |
| K232075 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2024-02-23 | Dual Track | PDF ↗ |
| K200788 | Assure Titanium Blood Glucose Monitoring System | Arkray, Inc. | 2022-05-23 | Dual Track | PDF ↗ |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2018-12-13 | Dual Track | PDF ↗ |
| K182552 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2018-12-13 | Dual Track | PDF ↗ |
| K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2018-07-12 | Dual Track | PDF ↗ |
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2017-01-06 | Special | PDF ↗ |
| K161856 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2016-11-15 | Special | PDF ↗ |
| K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2016-01-27 | Special | PDF ↗ |
| K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2015-05-20 | Traditional | PDF ↗ |
| K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | 2015-05-06 | Traditional | PDF ↗ |
| K132121 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | 2014-09-24 | Traditional | PDF ↗ |
Product code PZI · Class II · Clinical Chemistry. Data: openFDA.