FDA 510(k) Application Details - K233453

Device Classification Name	More FDA Info for this Device
510(K) Number	K233453
Device Name	Applied BiosystemsÖ TaqPathÖ COVID-19 Diagnostic PCR Kit
Applicant	Life Technologies Corporation 6055 Sunol Boulevard Pleasanton, CA 94566 US Other 510(k) Applications for this Company
Contact	Ian McGill Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2023
Decision Date	07/10/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review