FDA 510(k) Application Details - K212576

Device Classification Name	More FDA Info for this Device
510(K) Number	K212576
Device Name	MDx-Chex for BCID2
Applicant	Streck, Inc 7002 S. 109th Street La Vista, NE 68128 US Other 510(k) Applications for this Company
Contact	Deborah S. Kipp Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2021
Decision Date	01/19/2022
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