FDA 510(k) Application Details - K992576

Device Classification Name	Urinalysis Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K992576
Device Name	Urinalysis Controls (Assayed And Unassayed)
Applicant	CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 AUSTIN, TX 78744-1832 US Other 510(k) Applications for this Company
Contact	RUSTY SEWELL 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	08/02/1999
Decision Date	09/03/1999
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