FDA 510(k) Application Details - K231223

Device Classification Name	More FDA Info for this Device
510(K) Number	K231223
Device Name	MDx-Chex for BC-GN
Applicant	Streck 7002 S. 109th Street La Vista, NE 68128 US Other 510(k) Applications for this Company
Contact	Cody A. Janssen 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	04/28/2023
Decision Date	07/27/2023
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