FDA 510(k) Application Details - K992143

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K992143
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. WHEAT RIDGE, CO 80033 US Other 510(k) Applications for this Company
Contact	LINDA K DILLON Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	JWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/1999
Decision Date	09/16/1999
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