510(k) K911557

ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN by Alamar Biosciences Laboratory, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1991
Date Received
April 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type