K230813 is an FDA 510(k) clearance for the BlueStar and BlueStar Rx. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on July 28, 2023, 126 days after receiving the submission on March 24, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K230813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2023 |
| Decision Date | July 28, 2023 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NDC - Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |