FDA 510(k) Application Details - K191030

Device Classification Name	More FDA Info for this Device
510(K) Number	K191030
Device Name	Applied BiosystemsÖ 3500 Dx Genetic Analyzer and Applied BiosystemsÖ 3500xL Dx Genetic Analyzer
Applicant	Life Technologies Corporation 5781 Van Allen Way Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Darcie Baynes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2019
Decision Date	02/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review