510(k) K853772

PRECEPT METHICILLIN by Austin Biological Laboratories — Product Code LTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
April 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Cards, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type