FDA 510(k) Application Details - K141338

Device Classification Name	More FDA Info for this Device
510(K) Number	K141338
Device Name	LIAT STREP A ASSAY
Applicant	IQUUM INC 700 NICKERSON ROAD MARLBOROUGH, MA 01762-4663 US Other 510(k) Applications for this Company
Contact	Lingjun Chen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2014
Decision Date	11/04/2014
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