FDA 510(k) Application Details - K980955

Device Classification Name	Susceptibility Test Discs, Antimicrobial   More FDA Info for this Device
510(K) Number	K980955
Device Name	Susceptibility Test Discs, Antimicrobial
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	866.1620   More FDA Info for this Regulation Number
Classification Product Code	JTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/1998
Decision Date	05/18/1998
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