K200788 is an FDA 510(k) clearance for the Assure Titanium Blood Glucose Monitoring System. This device is classified as a Prescription Use Blood Glucose Meter For Near-patient Testing (Class II - Special Controls, product code PZI).
Submitted by Arkray, Inc. (Kamigyo-Ku, JP). The FDA issued a Cleared decision on May 23, 2022, 788 days after receiving the submission on March 26, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345. 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..
| 510(k) Number | K200788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2020 |
| Decision Date | May 23, 2022 |
| Days to Decision | 788 days |
| Submission Type | Dual Track |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PZI - Prescription Use Blood Glucose Meter For Near-patient Testing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
| Definition | 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. |