Assure Titanium Blood Glucose Monitoring System
FDA 510(k) K200788 · Arkray, Inc.
510(k) numberK200788
Submission
- Device name
- Assure Titanium Blood Glucose Monitoring System
- Applicant
- Arkray, Inc.
Kamigyo-Ku, JP - Received
- March 26, 2020
- Decision date
- May 23, 2022
- 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.
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| 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 |
| K232075 | StatStrip Glucose Hospital Meter SystemPZI · Dual Track | Nova Biomedical Corporation | 02/23/2024SE |
| 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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Questions and answers
When was Assure Titanium Blood Glucose Monitoring System cleared by the FDA?
Assure Titanium Blood Glucose Monitoring System (K200788) received a 510(k) decision of Substantially Equivalent on May 23, 2022, 788 days after the submission was received.
What is the product code of K200788?
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.