FDA 510(k) Application Details - K221309

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K221309
Device Name	Device, Automated Cell-Locating
Applicant	SigTuple Technologies Pvt. Ltd. First Floor, L-162, 14th Cross Road, Sector 6, HSR Layout Bangalore 560102 IN Other 510(k) Applications for this Company
Contact	Tathagato Rai Dastidar Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	JOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2022
Decision Date	09/19/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review