510(k) K931864

MARTIN LEWIS WITH LINOCMYCIN by Hardy Diagnostics — Product Code JTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1993
Date Received
April 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, For Isolation Of Pathogenic Neisseria
Device Class
Class II
Regulation Number
866.2410
Review Panel
MI
Submission Type