Cleared Traditional

AI100 with Shonit

K221309 · Sigtuple Technologies Pvt. , Ltd. · Hematology

Sep 2023

Decision

502d

Days

Class 2

Risk

About This 510(k) Submission

K221309 is an FDA 510(k) clearance for the AI100 with Shonit, a Device, Automated Cell-locating (Class II — Special Controls, product code JOY), submitted by Sigtuple Technologies Pvt. , Ltd. (Bangalore, IN). The FDA issued a Cleared decision on September 19, 2023, 502 days after receiving the submission on May 5, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5260.

Submission Details

510(k) Number	K221309 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2022
Decision Date	September 19, 2023
Days to Decision	502 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF