Devices · SigTuple Technologies Pvt. Ltd.
AI100 with Shonit
SigTuple Technologies Pvt. Ltd. is listed for AI100 with Shonit (K221309). The FDA list gives September 19, 2023 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JOY. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221309
- Date of final decision
- September 19, 2023
- Company on the FDA list
- SigTuple Technologies Pvt. Ltd.
- Lead panel
- Hematology
- Primary product code
- JOY
- openFDA device name for the code
- Device, Automated Cell-Locating
- Device class
- 2
- Regulation number
- 864.5260
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary