FDA 510(k) Application Details - K170091

Device Classification Name	Urinalysis Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K170091
Device Name	Urinalysis Controls (Assayed And Unassayed)
Applicant	Streck 7002 S. 109th Street La Vista, NE 68128 US Other 510(k) Applications for this Company
Contact	Deborah Kipp Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2017
Decision Date	02/09/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review